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A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)

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ClinicalTrials.gov Identifier: NCT01760447
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : October 5, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Sitagliptin plus metformin
Drug: Placebo to metformin
Drug: Metformin
Drug: Placebo to sitagliptin plus metformin
Drug: Sitagliptin plus metformin XR
Drug: Placebo to metformin XR
Drug: Insulin
Drug: Placebo to sitagliptin plus metformin XR
Drug: Metformin XR
Enrollment 223
Recruitment Details

The study recruited participants in clinics/clinical offices in 28 countries.

One participant who was randomized to the arm "Sitagliptin/Metformin" withdrew prior to treatment, then was re-randomized into the study. Only the second randomization is counted for Participant Flow and All-Cause Mortality, so this participant is not counted twice.

Pre-assignment Details The Pre-Assignment Period included a one-week single-blind placebo run-in prior to randomization during which participants received metformin with sitagliptin/metformin placebo or metformin XR with sitagliptin/metformin XR placebo each day.
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR
Hide Arm/Group Description Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170. Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170. Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289. Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
Period Title: Weeks 0-20
Started 62 [1] 62 47 51
Treated 62 62 45 51
Completed 59 62 42 47
Not Completed 3 0 5 4
Reason Not Completed
Consent withdrawn by Parent/Guardian             0             0             1             3
Withdrawal by Subject             2             0             1             0
Lost to Follow-up             1             0             1             1
Randomized but not treated             0             0             2             0
[1]
The first randomization for the participant who withdrew and re-randomized is not counted in the 62.
Period Title: Weeks 20-54
Started 28 [1] 30 [1] 42 47
Completed 25 28 39 43
Not Completed 3 2 3 4
Reason Not Completed
Consent withdrawn by Parent/Guardian             1             1             1             0
Withdrawal by Subject             2             1             1             2
Lost to Follow-up             0             0             1             2
[1]
MK-0431A-170 added Weeks 20-54 via amendment, but not all participants were eligible for this period
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Total
Hide Arm/Group Description Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170. Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170. Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289. Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289. Total of all reporting groups
Overall Number of Baseline Participants 62 62 45 51 220
Hide Baseline Analysis Population Description
The baseline characteristics data are presented for all treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 62 participants 45 participants 51 participants 220 participants
14.4  (2.2) 13.9  (1.8) 14.8  (1.9) 14.9  (1.6) 14.4  (1.9)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 45 participants 51 participants 220 participants
In utero
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Preterm newborn infants (gestational age < 37 wks)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Newborns (0-27 days)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Infants and toddlers (28 days-23 months)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Children (2-11 years)
10
  16.1%
7
  11.3%
3
   6.7%
1
   2.0%
21
   9.5%
Adolescents (12-17 years)
52
  83.9%
55
  88.7%
42
  93.3%
50
  98.0%
199
  90.5%
Adults (18-64 years)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
From 65-84 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
85 years and over
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 45 participants 51 participants 220 participants
Female
41
  66.1%
40
  64.5%
32
  71.1%
32
  62.7%
145
  65.9%
Male
21
  33.9%
22
  35.5%
13
  28.9%
19
  37.3%
75
  34.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 45 participants 51 participants 220 participants
Hispanic or Latino
23
  37.1%
23
  37.1%
11
  24.4%
20
  39.2%
77
  35.0%
Not Hispanic or Latino
35
  56.5%
36
  58.1%
29
  64.4%
28
  54.9%
128
  58.2%
Unknown or Not Reported
4
   6.5%
3
   4.8%
5
  11.1%
3
   5.9%
15
   6.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants 62 participants 45 participants 51 participants 220 participants
American Indian or Alaska Native
0
   0.0%
1
   1.6%
3
   6.7%
9
  17.6%
13
   5.9%
Asian
21
  33.9%
22
  35.5%
15
  33.3%
6
  11.8%
64
  29.1%
Native Hawaiian or Other Pacific Islander
1
   1.6%
1
   1.6%
0
   0.0%
0
   0.0%
2
   0.9%
Black or African American
2
   3.2%
2
   3.2%
2
   4.4%
4
   7.8%
10
   4.5%
White
24
  38.7%
23
  37.1%
22
  48.9%
27
  52.9%
96
  43.6%
More than one race
14
  22.6%
13
  21.0%
3
   6.7%
5
   9.8%
35
  15.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Glycated Hemoglobin (A1C)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 62 participants 62 participants 45 participants 51 participants 220 participants
8.02  (1.22) 8.13  (1.08) 7.87  (0.94) 7.97  (1.05) 8.0  (1.1)
[1]
Measure Description: Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
1.Primary Outcome
Title Change From Baseline in A1C at Week 20
Hide Description Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Mean change from baseline at Week 20 was estimated from a longitudinal data analysis model.
Time Frame Baseline and Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication and who had at least 1 measurement of A1C. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 107 113
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of glycated hemoglobin
-0.58
(-0.94 to -0.22)
-0.09
(-0.43 to 0.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The Least Squares (LS) Mean for the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled."
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.018
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 95%
-0.90 to -0.09
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Who Experienced ≥1 Adverse Event During Weeks 0-20
Hide Description The number of participants experiencing ≥1 adverse event during Weeks 0-20 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication.
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 62 62 45 51 107 113
Measure Type: Count of Participants
Unit of Measure: Participants
42
  67.7%
46
  74.2%
29
  64.4%
30
  58.8%
71
  66.4%
76
  67.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The percentage of participants who experienced ≥1 adverse event for the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled."
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-13.9 to 11.3
Estimation Comments The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.
3.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event During Weeks 0-20
Hide Description The number of participants who discontinued from study drug due to an adverse event during Weeks 0-20 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication.
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 62 62 45 51 107 113
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.6%
2
   3.2%
2
   4.4%
2
   3.9%
3
   2.8%
4
   3.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled."
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-6.2 to 5.0
Estimation Comments The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.
4.Primary Outcome
Title Number of Participants Who Experienced ≥1 Adverse Event During Weeks 0-56
Hide Description The number of participants experiencing ≥1 adverse event during Weeks 0-56 were reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to approximately Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20.
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 28 30 42 47 70 77
Measure Type: Count of Participants
Unit of Measure: Participants
26
  92.9%
27
  90.0%
36
  85.7%
39
  83.0%
62
  88.6%
66
  85.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The percentage of participants who experienced ≥1 adverse event for the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled."
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 2.9
Confidence Interval (2-Sided) 95%
-8.9 to 14.4
Estimation Comments The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.
5.Primary Outcome
Title Number of Participants Who Discontinued Study Drug Due to Experiencing an Adverse Event During Weeks 0-54
Hide Description The number of participants who discontinued from study drug due to an adverse event during Weeks 0-54 was reported. An adverse event is defined as any untoward medical occurrence in a person administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Time Frame Up to Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20.
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 28 30 42 47 70 77
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.6%
1
   3.3%
1
   2.4%
3
   6.4%
2
   2.9%
4
   5.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The percentage of participants who discontinued study drug due to experiencing an adverse event for the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled."
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-10.1 to 5.8
Estimation Comments The Miettinen and Nurminen methodology was used to calculate the difference and 95% confidence interval.
6.Secondary Outcome
Title Change From Baseline in A1C at Week 54
Hide Description A1C is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Mean change from baseline at Week 54 was estimated from a longitudinal data analysis model.
Time Frame Baseline and Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication, had ≥1 measurement of A1C, and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and -289, pooled by receipt of experimental drug or placebo.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 70 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percentage of glycated hemoglobin
0.35
(-0.48 to 1.19)
0.73
(-0.08 to 1.54)
7.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 20
Hide Description Blood glucose was measured on a fasting basis. Mean change from baseline at Week 20 was estimated from a longitudinal data analysis model.
Time Frame Baseline and Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication, and who had at least 1 measurement of FPG. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 107 113
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-2.5
(-16.7 to 11.7)
8.3
(-5.0 to 21.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The Least Squares (LS) Mean for the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled."
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.159
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -10.8
Confidence Interval (2-Sided) 95%
-25.9 to 4.3
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in FPG at Week 54
Hide Description Blood glucose was measured on a fasting basis. Mean change from baseline at Week 54 was estimated from a longitudinal data analysis model.
Time Frame Baseline and Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication, had ≥1 measurement of FPG, and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and -289, pooled by receipt of experimental drug or placebo.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 70 77
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
16.8
(-8.4 to 42.0)
16.9
(-7.0 to 40.8)
9.Secondary Outcome
Title Percentage of Participants With A1C at Goal (<7.0%) at Week 20
Hide Description Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (<7.0%) at Week 20 was presented.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 107 113
Measure Type: Number
Unit of Measure: Percentage of participants
43.0 31.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The percentage of participants with A1C at the A1C goal (<7.0%) in the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled." For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 16.0
Confidence Interval (2-Sided) 95%
2.9 to 28.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants With A1C at Goal (<6.5%) at Week 20
Hide Description Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (<6.5%) at Week 20 was presented.
Time Frame Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 107 113
Measure Type: Number
Unit of Measure: Percentage of participants
29.0 20.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The percentage of participants with A1C at the A1C goal (<6.5%) in the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled." For estimating the treatment difference, when the A1C result for a participant at Week 20 was not available, a multiple imputation method was used to impute whether the participant had met the goal.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentage
Estimated Value 12.2
Confidence Interval (2-Sided) 95%
0.0 to 24.8
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With A1C at Goal (<7.0%) at Week 54
Hide Description Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (<7.0%) at Week 54 was presented.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 70 77
Measure Type: Number
Unit of Measure: Percentage of participants
31.4 27.3
12.Secondary Outcome
Title Percentage of Participants With A1C at Goal (<6.5%) at Week 54
Hide Description Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100. Percentage of participants with A1C at goal (<6.5%) at Week 54 was presented.
Time Frame Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20. As defined in the protocols, these analyses were conducted in participants pooled from protocols MK-0431A-170 and MK-0431A-289, pooled according to receipt of experimental drug or placebo comparator.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 70 77
Measure Type: Number
Unit of Measure: Percentage of participants
18.6 19.5
13.Secondary Outcome
Title Percentage of Participants Initiating Glycemic Rescue Therapy by Week 20
Hide Description Percentage of participants who initiated glycemic rescue therapy prior to Week 20 was reported.
Time Frame Up to Week 20
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication.
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170.
Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289.
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 62 62 45 51 107 113
Measure Type: Number
Unit of Measure: Percentage of participants
3.2 19.4 4.4 13.7 3.7 16.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled, Metformin and Metformin XR Pooled
Comments The percentage of participants initiating glycemic rescue therapy in the arm "Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" is compared against that of "Metformin and Metformin XR Pooled."
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Log-Rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier Difference in Percentage
Estimated Value -13.2
Confidence Interval (2-Sided) 95%
-21.1 to -5.3
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants Initiating Insulin Glargine During Weeks 20-54
Hide Description Percentage of participants who initiated insulin glargine therapy from Weeks 20 through 54 was reported.
Time Frame Week 20 up to Week 54
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication and continued in the study beyond Week 20 without initiating glycemic rescue therapy before Week 20. As defined in the protocols, these analyses were on participants pooled from protocols MK-0431A-170 and -289, pooled by receipt of drug or placebo.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 66 64
Measure Type: Number
Unit of Measure: Percentage of participants
22.7 26.6
15.Other Pre-specified Outcome
Title Baseline A1C
Hide Description Glycated hemoglobin (A1C) is a blood marker used to report average blood glucose levels over prolonged periods of time. Percentage A1C is the ratio of glycated hemoglobin to total hemoglobin x 100.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all randomized participants who received ≥1 dose of study medication and had a baseline measurement of A1C. Baseline A1C data for non-pooled arms are listed in the Baseline Characteristics module.
Arm/Group Title Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description:
This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289).
This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
Overall Number of Participants Analyzed 107 113
Mean (Standard Deviation)
Unit of Measure: Percentage of glycated hemoglobin
7.96  (1.11) 8.06  (1.07)
Time Frame Up to 56 weeks for non-serious adverse events. Up to approximately 76 weeks for serious adverse events. Up to approximately 78 weeks for all-cause mortality.
Adverse Event Reporting Description

"Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled" = "Sitagliptin/Metformin" plus "Sitagliptin/Metformin XR." "Metformin and Metformin XR Pooled" = "Metformin" plus "Metformin XR."

Non-serious and serious adverse events are recorded for all treated participants.

All-cause mortality is recorded for all randomized participants.

 
Arm/Group Title Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Hide Arm/Group Description Participants received one tablet of sitagliptin/metformin and one tablet of metformin-placebo, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170. Participants received one tablet of metformin and one tablet of placebo to sitagliptin/metformin, administered twice daily prior to the morning and evening meals, for up to 20 weeks in the base study alone, or for up to 54 weeks if the participant also entered the extension study. Participants in this arm were enrolled in protocol MK-0431A-170. Participants received two tablets of sitagliptin/metformin XR and two tablets of metformin XR placebo, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289. Participants received two tablets of metformin XR and two tablets of placebo to sitagliptin/metformin XR, administered once daily with a meal, for up to 54 weeks. Participants in this arm were enrolled in protocol MK-0431A-289. This reporting group contains the pooled population of treated participants from the experimental-drug groups "Sitagliptin/Metformin" (from protocol MK-0431A-170) and "Sitagliptin/Metformin XR" (from protocol MK-0431A-289). This reporting group contains the pooled population of treated participants from the placebo groups "Metformin" (from protocol MK-0431A-170) and "Metformin XR" (from protocol MK-0431A-289).
All-Cause Mortality
Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/62 (1.61%)      0/62 (0.00%)      0/47 (0.00%)      0/51 (0.00%)      1/109 (0.92%)      0/113 (0.00%)    
Hide Serious Adverse Events
Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/62 (6.45%)      3/62 (4.84%)      3/45 (6.67%)      3/51 (5.88%)      7/107 (6.54%)      6/113 (5.31%)    
Gastrointestinal disorders             
Abdominal pain upper  1  0/62 (0.00%)  0 0/62 (0.00%)  0 0/45 (0.00%)  0 1/51 (1.96%)  1 0/107 (0.00%)  0 1/113 (0.88%)  1
Diarrhoea  1  0/62 (0.00%)  0 0/62 (0.00%)  0 1/45 (2.22%)  1 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
Vomiting  1  0/62 (0.00%)  0 0/62 (0.00%)  0 0/45 (0.00%)  0 1/51 (1.96%)  1 0/107 (0.00%)  0 1/113 (0.88%)  1
General disorders             
Death  1  1/62 (1.61%)  1 0/62 (0.00%)  0 0/45 (0.00%)  0 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
Immune system disorders             
Type I hypersensitivity  1  1/62 (1.61%)  1 0/62 (0.00%)  0 0/45 (0.00%)  0 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
Infections and infestations             
Gastroenteritis  1  0/62 (0.00%)  0 0/62 (0.00%)  0 1/45 (2.22%)  1 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
H1N1 influenza  1  0/62 (0.00%)  0 0/62 (0.00%)  0 0/45 (0.00%)  0 1/51 (1.96%)  1 0/107 (0.00%)  0 1/113 (0.88%)  1
Pyelonephritis  1  1/62 (1.61%)  1 0/62 (0.00%)  0 0/45 (0.00%)  0 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
Upper respiratory tract infection  1  0/62 (0.00%)  0 0/62 (0.00%)  0 1/45 (2.22%)  1 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
Investigations             
Blood glucose increased  1  0/62 (0.00%)  0 1/62 (1.61%)  1 0/45 (0.00%)  0 0/51 (0.00%)  0 0/107 (0.00%)  0 1/113 (0.88%)  1
Metabolism and nutrition disorders             
Hyperglycaemia  1  0/62 (0.00%)  0 1/62 (1.61%)  1 0/45 (0.00%)  0 1/51 (1.96%)  1 0/107 (0.00%)  0 2/113 (1.77%)  2
Musculoskeletal and connective tissue disorders             
Synovial cyst  1  1/62 (1.61%)  1 0/62 (0.00%)  0 0/45 (0.00%)  0 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
Nervous system disorders             
Epilepsy  1  0/62 (0.00%)  0 1/62 (1.61%)  1 0/45 (0.00%)  0 0/51 (0.00%)  0 0/107 (0.00%)  0 1/113 (0.88%)  1
Psychiatric disorders             
Suicide attempt  1  0/62 (0.00%)  0 0/62 (0.00%)  0 0/45 (0.00%)  0 1/51 (1.96%)  1 0/107 (0.00%)  0 1/113 (0.88%)  1
Respiratory, thoracic and mediastinal disorders             
Asthma  1  1/62 (1.61%)  1 0/62 (0.00%)  0 0/45 (0.00%)  0 0/51 (0.00%)  0 1/107 (0.93%)  1 0/113 (0.00%)  0
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin/Metformin Metformin Sitagliptin/Metformin XR Metformin XR Sitagliptin/Metformin and Sitagliptin/Metformin XR Pooled Metformin and Metformin XR Pooled
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/62 (54.84%)      40/62 (64.52%)      30/45 (66.67%)      36/51 (70.59%)      64/107 (59.81%)      76/113 (67.26%)    
Gastrointestinal disorders             
Abdominal pain  1  2/62 (3.23%)  2 4/62 (6.45%)  4 4/45 (8.89%)  4 4/51 (7.84%)  4 6/107 (5.61%)  6 8/113 (7.08%)  8
Abdominal pain upper  1  1/62 (1.61%)  2 2/62 (3.23%)  2 0/45 (0.00%)  0 3/51 (5.88%)  4 1/107 (0.93%)  2 5/113 (4.42%)  6
Diarrhoea  1  7/62 (11.29%)  8 4/62 (6.45%)  4 1/45 (2.22%)  1 3/51 (5.88%)  10 8/107 (7.48%)  9 7/113 (6.19%)  14
Nausea  1  2/62 (3.23%)  5 5/62 (8.06%)  5 4/45 (8.89%)  6 2/51 (3.92%)  3 6/107 (5.61%)  11 7/113 (6.19%)  8
Infections and infestations             
Gastroenteritis  1  5/62 (8.06%)  6 3/62 (4.84%)  3 3/45 (6.67%)  3 2/51 (3.92%)  2 8/107 (7.48%)  9 5/113 (4.42%)  5
Influenza  1  1/62 (1.61%)  1 4/62 (6.45%)  5 2/45 (4.44%)  3 3/51 (5.88%)  5 3/107 (2.80%)  4 7/113 (6.19%)  10
Nasopharyngitis  1  7/62 (11.29%)  11 7/62 (11.29%)  7 1/45 (2.22%)  2 2/51 (3.92%)  3 8/107 (7.48%)  13 9/113 (7.96%)  10
Pharyngitis  1  1/62 (1.61%)  1 3/62 (4.84%)  3 1/45 (2.22%)  1 5/51 (9.80%)  6 2/107 (1.87%)  2 8/113 (7.08%)  9
Upper respiratory tract infection  1  9/62 (14.52%)  11 6/62 (9.68%)  8 5/45 (11.11%)  9 3/51 (5.88%)  5 14/107 (13.08%)  20 9/113 (7.96%)  13
Urinary tract infection  1  0/62 (0.00%)  0 5/62 (8.06%)  6 3/45 (6.67%)  3 1/51 (1.96%)  1 3/107 (2.80%)  3 6/113 (5.31%)  7
Investigations             
Alanine aminotransferase increased  1  2/62 (3.23%)  3 3/62 (4.84%)  3 3/45 (6.67%)  3 3/51 (5.88%)  3 5/107 (4.67%)  6 6/113 (5.31%)  6
Blood creatine phosphokinase increased  1  3/62 (4.84%)  3 1/62 (1.61%)  1 3/45 (6.67%)  3 1/51 (1.96%)  1 6/107 (5.61%)  6 2/113 (1.77%)  2
Blood glucose increased  1  3/62 (4.84%)  4 0/62 (0.00%)  0 2/45 (4.44%)  2 3/51 (5.88%)  5 5/107 (4.67%)  6 3/113 (2.65%)  5
Creatinine renal clearance increased  1  4/62 (6.45%)  4 0/62 (0.00%)  0 0/45 (0.00%)  0 0/51 (0.00%)  0 4/107 (3.74%)  4 0/113 (0.00%)  0
Urine albumin/creatinine ratio increased  1  4/62 (6.45%)  5 2/62 (3.23%)  2 0/45 (0.00%)  0 0/51 (0.00%)  0 4/107 (3.74%)  5 2/113 (1.77%)  2
Metabolism and nutrition disorders             
Hyperglycaemia  1  3/62 (4.84%)  3 5/62 (8.06%)  6 3/45 (6.67%)  3 4/51 (7.84%)  4 6/107 (5.61%)  6 9/113 (7.96%)  10
Hypoglycaemia  1  10/62 (16.13%)  106 6/62 (9.68%)  15 9/45 (20.00%)  70 10/51 (19.61%)  45 19/107 (17.76%)  176 16/113 (14.16%)  60
Nervous system disorders             
Headache  1  3/62 (4.84%)  4 8/62 (12.90%)  10 2/45 (4.44%)  4 10/51 (19.61%)  15 5/107 (4.67%)  8 18/113 (15.93%)  25
Respiratory, thoracic and mediastinal disorders             
Cough  1  2/62 (3.23%)  2 3/62 (4.84%)  4 3/45 (6.67%)  3 2/51 (3.92%)  2 5/107 (4.67%)  5 5/113 (4.42%)  6
Oropharyngeal pain  1  2/62 (3.23%)  2 1/62 (1.61%)  1 3/45 (6.67%)  3 1/51 (1.96%)  6 5/107 (4.67%)  5 2/113 (1.77%)  7
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
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.
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Disclosure
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01760447    
Obsolete Identifiers: NCT01472367
Other Study ID Numbers: 0431A-289
2012-004035-23 ( EudraCT Number )
2011-002529-23 ( EudraCT Number )
2014-003583-20 ( EudraCT Number )
MK-0431A-170 ( Other Identifier: Merck Protocol Number )
MK-0431A-289 ( Other Identifier: Merck Protocol Number )
CTRI/2012/09/003025 ( Registry Identifier: CTRI )
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: September 11, 2020
Results First Posted: October 5, 2020
Last Update Posted: November 16, 2020