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Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01336738
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : August 6, 2013
Last Update Posted : August 6, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Diabetes, Type 2
Interventions Drug: Placebo
Drug: 150 mg PF-04991532
Drug: 450 mg PF-04991532
Drug: 750 mg PF-04991532
Drug: Sitagliptin 100 mg
Enrollment 266
Recruitment Details  
Pre-assignment Details All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally once daily along with background metformin immediate release tablets, during the 2-week run-in period. Compliant participants were then randomized to study treatments for 12 weeks.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Period Title: Overall Study
Started 52 54 53 54 53
Completed 45 45 45 47 43
Not Completed 7 9 8 7 10
Reason Not Completed
Adverse Event             0             3             2             1             3
Lost to Follow-up             2             1             2             2             2
Did not meet entrance criteria             0             1             0             0             0
Protocol Violation             0             1             0             0             0
Withdrawal by Subject             2             0             2             1             1
Other             3             3             2             3             4
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo Total
Hide Arm/Group Description PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 52 54 53 54 53 266
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 54 participants 53 participants 54 participants 53 participants 266 participants
55.3  (9.9) 55.1  (9.3) 55.5  (7.3) 57.8  (8.3) 55.6  (8.5) 55.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 54 participants 53 participants 54 participants 53 participants 266 participants
Female
16
  30.8%
24
  44.4%
17
  32.1%
23
  42.6%
14
  26.4%
94
  35.3%
Male
36
  69.2%
30
  55.6%
36
  67.9%
31
  57.4%
39
  73.6%
172
  64.7%
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12
Hide Description HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description:
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Overall Number of Participants Analyzed 52 53 52 54 53
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin
Baseline (n=52, 53, 52, 54, 53) 8.34  (0.906) 8.19  (0.947) 7.96  (1.030) 7.97  (1.086) 8.55  (1.351)
Change at Week 12 (n=44, 44, 43, 48, 43) -0.17  (0.922) -0.57  (0.753) -0.70  (0.790) -0.78  (0.721) -0.21  (0.921)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Treatment difference and 80% confidence interval (CI) were based on LS mean. A mixed model repeated measure (MMRM) analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6803
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value 0.08
Confidence Interval (2-Sided) 80%
-0.13 to 0.29
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.164
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 80%
-0.71 to -0.28
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.166
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 80%
-0.80 to -0.36
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.168
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.71
Confidence Interval (2-Sided) 80%
-0.91 to -0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.162
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12
Hide Description [Not Specified]
Time Frame Baseline, Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description:
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Overall Number of Participants Analyzed 52 53 52 54 53
Mean (Standard Deviation)
Unit of Measure: milligram/deciliter (mg/dL)
Baseline (n=52, 53, 52, 54, 53) 172.68  (39.612) 169.16  (41.703) 159.11  (44.878) 158.38  (42.502) 183.61  (57.517)
Change at Week 1 (n=50, 51, 49, 49, 51) 0.87  (27.059) 1.63  (25.373) -1.55  (19.826) -13.72  (24.445) -4.21  (33.274)
Change at Week 2 (n=50, 51, 51, 50, 47) -4.48  (23.488) 4.13  (30.662) -5.26  (21.466) -15.70  (29.704) -3.72  (27.797)
Change at Week 4 (n=49, 49, 49, 50, 45) 1.13  (28.589) -5.14  (29.757) -6.68  (20.582) -21.86  (29.063) -4.28  (34.304)
Change at Week 8 (n=46, 44, 44, 47, 45) 3.69  (29.232) -1.49  (33.421) 2.95  (21.892) -14.05  (21.646) 2.18  (37.322)
Change at Week 12 (n=45, 44, 44, 48, 43) 0.08  (36.122) 5.87  (33.092) 6.86  (28.602) -17.64  (30.779) -0.03  (45.784)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4757
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.78
Confidence Interval (2-Sided) 95%
-6.64 to 14.20
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.292
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8031
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.32
Confidence Interval (2-Sided) 95%
-9.11 to 11.75
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.296
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5490
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.22
Confidence Interval (2-Sided) 95%
-13.78 to 7.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.364
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0051
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -15.07
Confidence Interval (2-Sided) 95%
-25.58 to -4.55
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.340
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6291
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.43
Confidence Interval (2-Sided) 95%
-12.31 to 7.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.020
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4396
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.87
Confidence Interval (2-Sided) 95%
-5.98 to 13.72
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.001
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1934
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.56
Confidence Interval (2-Sided) 95%
-16.46 to 3.34
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.030
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -17.32
Confidence Interval (2-Sided) 95%
-27.24 to -7.40
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.039
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5479
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 3.13
Confidence Interval (2-Sided) 95%
-7.11 to 13.37
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.201
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4276
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -4.14
Confidence Interval (2-Sided) 95%
-14.39 to 6.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.209
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1596
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -7.38
Confidence Interval (2-Sided) 95%
-17.69 to 2.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.235
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -22.83
Confidence Interval (2-Sided) 95%
-33.06 to -12.60
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.198
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8509
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-12.63 to 10.43
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.855
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1505
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.53
Confidence Interval (2-Sided) 95%
-20.17 to 3.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.913
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2662
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.62
Confidence Interval (2-Sided) 95%
-18.31 to 5.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.940
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -21.52
Confidence Interval (2-Sided) 95%
-32.97 to -10.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.818
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7724
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.01
Confidence Interval (2-Sided) 95%
-15.68 to 11.66
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.940
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9202
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-14.47 to 13.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.986
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8183
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.61
Confidence Interval (2-Sided) 95%
-15.40 to 12.18
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.998
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -24.96
Confidence Interval (2-Sided) 95%
-38.40 to -11.53
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.821
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8
Hide Description HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Time Frame Baseline, Week 1, 2, 4, 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description:
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Overall Number of Participants Analyzed 52 53 52 54 53
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin
Change at Week 1 (n=50, 51, 49, 49, 48) -0.04  (0.227) -0.03  (0.210) -0.13  (0.217) -0.07  (0.200) -0.02  (0.287)
Change at Week 2 (n=50, 52, 49, 49, 47) -0.04  (0.349) -0.14  (0.288) -0.18  (0.271) -0.23  (0.311) -0.07  (0.372)
Change at Week 4 (n=48, 49, 48, 50, 46) -0.22  (0.475) -0.34  (0.392) -0.40  (0.421) -0.42  (0.483) -0.16  (0.591)
Change at Week 8 (n=45, 44, 45, 47, 45) -0.21  (0.728) -0.50  (0.562) -0.66  (0.772) -0.71  (0.713) -0.22  (0.762)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2327
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.04
Confidence Interval (2-Sided) 80%
-0.10 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.048
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3580
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 80%
-0.08 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.048
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0036
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 80%
-0.20 to -0.07
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.049
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 1: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1251
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 80%
-0.12 to 0.01
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.049
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3466
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.03
Confidence Interval (2-Sided) 80%
-0.11 to 0.06
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.066
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0439
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.11
Confidence Interval (2-Sided) 80%
-0.20 to -0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.066
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0040
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 80%
-0.27 to -0.09
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.067
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 2: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 80%
-0.29 to -0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.065
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1405
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 80%
-0.23 to 0.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.096
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 80%
-0.36 to -0.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.097
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.37
Confidence Interval (2-Sided) 80%
-0.50 to -0.24
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.098
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 4: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 80%
-0.46 to -0.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.094
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4887
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.00
Confidence Interval (2-Sided) 80%
-0.18 to 0.17
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.135
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0020
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 80%
-0.57 to -0.22
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.137
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 80%
-0.76 to -0.41
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.138
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 8: Treatment difference and 80% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline, baseline-by-time interaction as the covariates, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments One-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 80%
-0.76 to -0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.133
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels
Hide Description HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4% and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description:
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Overall Number of Participants Analyzed 44 44 43 48 43
Measure Type: Number
Unit of Measure: percentage of participants
< 6.5% 4.5 9.1 23.3 14.6 11.6
< 7% 13.6 36.4 60.5 39.6 16.3
5.Secondary Outcome
Title Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12
Hide Description Overweight or obesity increases the risk for developing diabetes. The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c.
Time Frame Baseline, Week 1, 2, 4, 8, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies participants who were evaluable at specific time point for each treatment arm, respectively.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description:
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Overall Number of Participants Analyzed 52 53 52 54 53
Mean (Standard Deviation)
Unit of Measure: kilogram (kg)
Baseline (n=52, 53, 52, 54, 53) 92.57  (19.957) 88.91  (22.781) 86.08  (17.787) 87.48  (19.883) 87.43  (19.351)
Change at Week 1 (n=50, 51, 49, 51, 51) -0.10  (1.176) -0.31  (1.091) -0.34  (1.100) 0.14  (0.982) -0.33  (1.050)
Change at Week 2 (n=50, 52, 51, 50, 48) -0.12  (1.189) -0.33  (1.175) -0.38  (1.115) -0.00  (1.364) -0.37  (0.885)
Change at Week 4 (n=49, 49, 49, 50, 46) -0.18  (1.357) -0.72  (1.499) -0.34  (1.486) 0.15  (1.170) -0.52  (1.139)
Change at Week 8 (n=46, 44, 45, 48, 45) -0.27  (1.865) -0.66  (2.047) -0.45  (2.026) -0.21  (2.059) -0.60  (1.444)
Change at Week 12 (n=45, 44, 45, 48, 43) -0.91  (1.880) -0.82  (2.126) -0.90  (2.421) -0.22  (1.993) -0.95  (2.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2067
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.28
Confidence Interval (2-Sided) 95%
-0.16 to 0.73
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.225
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8602
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.40 to 0.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.224
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9200
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.47 to 0.42
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.225
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 1: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0399
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.02 to 0.90
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.223
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2266
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.29
Confidence Interval (2-Sided) 95%
-0.18 to 0.77
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.242
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8493
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.43 to 0.52
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.241
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9511
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.49 to 0.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.242
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 2: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1369
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
-0.11 to 0.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.241
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1562
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.39
Confidence Interval (2-Sided) 95%
-0.15 to 0.92
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.272
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4913
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.72 to 0.35
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.272
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5130
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.18
Confidence Interval (2-Sided) 95%
-0.36 to 0.71
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.272
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 4: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0298
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.06 to 1.12
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.269
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3196
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
-0.35 to 1.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.363
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8884
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.77 to 0.67
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.367
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7325
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.59 to 0.84
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.365
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 8: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3395
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.34
Confidence Interval (2-Sided) 95%
-0.36 to 1.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.357
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection PF-04991532 150 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7514
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.68 to 0.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.410
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection PF-04991532 450 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7529
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.13
Confidence Interval (2-Sided) 95%
-0.68 to 0.94
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.413
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection PF-04991532 750 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9638
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.79 to 0.83
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.411
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg, Placebo
Comments Week 12: Treatment difference and 95% CI were based on LS mean. A MMRM analysis was performed with treatment, time and treatment-by-time interaction as fixed effects, baseline as the covariate, time was repeated for participant.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0962
Comments Two-sided p-value was calculated.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
-0.12 to 1.47
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.404
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline
Hide Description Overweight or obesity increases the risk for developing diabetes. Participants with >= 1% or >= 2% body weight gain from baseline signifies a higher risk of diabetes.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description:
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Overall Number of Participants Analyzed 45 44 45 48 43
Measure Type: Number
Unit of Measure: percentage of participants
>= 1% 17.78 18.18 15.56 29.17 23.26
>= 2% 6.67 11.36 11.11 14.58 6.98
7.Secondary Outcome
Title Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline
Hide Description The treatment of diabetes has been the recommendation to lose weight. As weight loss progresses and is maintained, an improvement of glycemia may be evidenced by a reduction in HbA1c. Participants with >= 1% or >= 2% body weight loss from baseline signifies an improvement of glycemia.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study medication. Here, N (number of participants analyzed) signify those who were evaluable for this measure.
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description:
PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Overall Number of Participants Analyzed 45 44 45 48 43
Measure Type: Number
Unit of Measure: percentage of participants
>= 1% 55.56 47.73 46.67 29.17 41.86
>= 2% 26.67 34.09 31.11 18.75 34.88
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Hide Arm/Group Description PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks. Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
All-Cause Mortality
PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/54 (0.00%)   0/53 (0.00%)   0/54 (0.00%)   0/53 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
PF-04991532 150 mg PF-04991532 450 mg PF-04991532 750 mg Sitagliptin 100 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/52 (32.69%)   20/54 (37.04%)   23/53 (43.40%)   14/54 (25.93%)   16/53 (30.19%) 
Gastrointestinal disorders           
Diarrhoea * 1  1/52 (1.92%)  1/54 (1.85%)  7/53 (13.21%)  2/54 (3.70%)  0/53 (0.00%) 
Dyspepsia * 1  2/52 (3.85%)  0/54 (0.00%)  1/53 (1.89%)  1/54 (1.85%)  0/53 (0.00%) 
Nausea * 1  2/52 (3.85%)  4/54 (7.41%)  4/53 (7.55%)  2/54 (3.70%)  0/53 (0.00%) 
Toothache * 1  1/52 (1.92%)  0/54 (0.00%)  2/53 (3.77%)  0/54 (0.00%)  0/53 (0.00%) 
Vomiting * 1  1/52 (1.92%)  2/54 (3.70%)  1/53 (1.89%)  0/54 (0.00%)  1/53 (1.89%) 
Infections and infestations           
Influenza * 1  2/52 (3.85%)  1/54 (1.85%)  0/53 (0.00%)  0/54 (0.00%)  1/53 (1.89%) 
Nasopharyngitis * 1  2/52 (3.85%)  2/54 (3.70%)  3/53 (5.66%)  0/54 (0.00%)  2/53 (3.77%) 
Pharyngitis * 1  0/52 (0.00%)  0/54 (0.00%)  2/53 (3.77%)  1/54 (1.85%)  0/53 (0.00%) 
Sinusitis * 1  1/52 (1.92%)  0/54 (0.00%)  1/53 (1.89%)  2/54 (3.70%)  2/53 (3.77%) 
Upper respiratory tract infection * 1  0/52 (0.00%)  5/54 (9.26%)  1/53 (1.89%)  1/54 (1.85%)  2/53 (3.77%) 
Urinary tract infection * 1  2/52 (3.85%)  0/54 (0.00%)  1/53 (1.89%)  1/54 (1.85%)  2/53 (3.77%) 
Injury, poisoning and procedural complications           
Contusion * 1  0/52 (0.00%)  2/54 (3.70%)  0/53 (0.00%)  0/54 (0.00%)  0/53 (0.00%) 
Investigations           
Blood glucose increased * 1  0/52 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  0/54 (0.00%)  2/53 (3.77%) 
Metabolism and nutrition disorders           
Dyslipidaemia * 1  2/52 (3.85%)  2/54 (3.70%)  1/53 (1.89%)  0/54 (0.00%)  0/53 (0.00%) 
Hyperglycaemia * 1  3/52 (5.77%)  1/54 (1.85%)  3/53 (5.66%)  0/54 (0.00%)  2/53 (3.77%) 
Hypoglycaemia * 1  1/52 (1.92%)  2/54 (3.70%)  0/53 (0.00%)  2/54 (3.70%)  1/53 (1.89%) 
Musculoskeletal and connective tissue disorders           
Pain in extremity * 1  0/52 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  2/54 (3.70%)  1/53 (1.89%) 
Nervous system disorders           
Headache * 1  1/52 (1.92%)  1/54 (1.85%)  3/53 (5.66%)  1/54 (1.85%)  1/53 (1.89%) 
Psychiatric disorders           
Insomnia * 1  0/52 (0.00%)  0/54 (0.00%)  0/53 (0.00%)  3/54 (5.56%)  0/53 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Oropharyngeal pain * 1  0/52 (0.00%)  1/54 (1.85%)  1/53 (1.89%)  1/54 (1.85%)  2/53 (3.77%) 
Vascular disorders           
Hypertension * 1  0/52 (0.00%)  3/54 (5.56%)  0/53 (0.00%)  0/54 (0.00%)  1/53 (1.89%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01336738     History of Changes
Other Study ID Numbers: B2611002
First Submitted: April 13, 2011
First Posted: April 18, 2011
Results First Submitted: June 5, 2013
Results First Posted: August 6, 2013
Last Update Posted: August 6, 2013