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Sitagliptin Added-on to Insulin Study (0431-051)

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ClinicalTrials.gov Identifier: NCT00395343
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : October 23, 2009
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: sitagliptin phosphate
Drug: Comparator : placebo (unspecified)
Enrollment 641
Recruitment Details

Phase III

First Patient In: 29-Jan-2007 Last Patient Last Visit: 13-Oct-2008; 100 study centers worldwide

Pre-assignment Details Patients at least 21 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥7.5 and ≤11.0%) on stable-dose insulin (alone or in combination with stable-dose metformin) were eligible to enter the 24 week study. 1-week screening, followed by a 2-week single-blind placebo run-in.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Period Title: Overall Study
Started 322 319
Completed 281 283
Not Completed 41 36
Reason Not Completed
Adverse Event             13             5
Lack of Efficacy             0             1
Lost to Follow-up             4             4
Physician Decision             2             4
Protocol Violation             6             8
Withdrawal by Subject             11             12
Other             5             2
Arm/Group Title Sitagliptin 100 mg q.d. Placebo Total
Hide Arm/Group Description The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). Total of all reporting groups
Overall Number of Baseline Participants 322 319 641
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 322 participants 319 participants 641 participants
58.3  (9.1) 57.2  (9.3) 57.8  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 319 participants 641 participants
Female
165
  51.2%
150
  47.0%
315
  49.1%
Male
157
  48.8%
169
  53.0%
326
  50.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 322 participants 319 participants 641 participants
White 228 219 447
Black 21 23 44
Asian 55 61 116
Other 18 16 34
A1C (Hemoglobin A1c)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 322 participants 319 participants 641 participants
8.7  (0.9) 8.6  (0.9) 8.7  (0.9)
1.Primary Outcome
Title Change From Baseline in A1C at Week 24
Hide Description A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description:
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Overall Number of Participants Analyzed 305 312
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.59
(-0.70 to -0.48)
-0.03
(-0.14 to 0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg q.d., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment; baseline; metformin stratum (on vs. not on metformin); insulin stratum (pre-mixed vs. intermediate or long-acting)
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.56
Confidence Interval 95%
-0.70 to -0.42
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description:
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Overall Number of Participants Analyzed 310 313
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-18.5
(-25.1 to -11.9)
-3.5
(-10.2 to 3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg q.d., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment; baseline; metformin stratum; insulin stratum
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -15.0
Confidence Interval 95%
-23.4 to -6.5
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
Hide Description Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description:
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Overall Number of Participants Analyzed 240 257
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-30.9
(-40.0 to -21.8)
5.2
(-3.6 to 13.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg q.d., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment; baseline; metformin stratum; insulin stratum
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -36.1
Confidence Interval 95%
-47.1 to -25.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24
Hide Description Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.)
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients who participated in the 10-point meal tolerance test and had a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description:
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Overall Number of Participants Analyzed 35 45
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
28.4
(5.4 to 56.6)
-8.1
(-22.6 to 9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg q.d., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment; log-scaled baseline value; metformin stratum; insulin stratum
Method of Estimation Estimation Parameter Geometric Mean Difference
Estimated Value 36.5
Confidence Interval 95%
8.9 to 64.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent of Patients With A1C < 7.0% at Week 24
Hide Description [Not Specified]
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description:
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Overall Number of Participants Analyzed 305 312
Measure Type: Number
Unit of Measure: Percent
12.8 5.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg q.d., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Based on a test of the odds ratio = 1, comparing the odds of having A1C <7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.
Method Logistic Regression
Comments Model terms: treatment; baseline; Metformin stratum; and insulin stratum
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.60
Confidence Interval 95%
1.89 to 6.85
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent of Patients With A1C < 6.5% at Week 24
Hide Description [Not Specified]
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description:
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Overall Number of Participants Analyzed 305 312
Measure Type: Number
Unit of Measure: Percent
2.3 1.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg q.d., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.584
Comments Based on a test of the odds ratio = 1, comparing the odds of having A1C <7.0% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.
Method Logistic Regression
Comments Model terms: treatment; baseline; Metformin stratum; and insulin stratum
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval 95%
0.45 to 4.18
Estimation Comments This parameter estimate and 95% confidence interval correspond to the odds of having A1C <6.5% at Week 24 in the Sitagliptin 100 mg q.d. group vs. the Placebo group.
7.Other Pre-specified Outcome
Title Change From Baseline in A1C at Week 24
Hide Description

A1C in subset of patients on long-acting or intermediate-acting insulin.

A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included the subset of patients on long-acting or intermediate-acting insulin with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description:
The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
Overall Number of Participants Analyzed 225 232
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.61
(-0.73 to -0.48)
-0.04
(-0.16 to 0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sitagliptin 100 mg q.d., Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments Model terms: treatment; baseline; metformin stratum; insulin stratum, treatment by insulin stratum interaction
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.56
Confidence Interval 95%
-0.72 to -0.40
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin 100 mg q.d. Placebo
Hide Arm/Group Description The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day). The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
All-Cause Mortality
Sitagliptin 100 mg q.d. Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sitagliptin 100 mg q.d. Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   20/322 (6.21%)   11/319 (3.45%) 
Cardiac disorders     
Any Cardiac disorders * 1  4/322 (1.24%)  5/319 (1.57%) 
Acute myocardial infarction * 1  1/322 (0.31%)  1/319 (0.31%) 
Angina pectoris * 1  2/322 (0.62%)  0/319 (0.00%) 
Angina unstable * 1  0/322 (0.00%)  1/319 (0.31%) 
Cardiac failure congestive * 1  0/322 (0.00%)  2/319 (0.63%) 
Coronary artery disease * 1  0/322 (0.00%)  1/319 (0.31%) 
Myocardial infarction * 1  0/322 (0.00%)  1/319 (0.31%) 
Trifascicular block * 1  1/322 (0.31%)  0/319 (0.00%) 
Gastrointestinal disorders     
Any Gastrointestinal Disorders * 1  2/322 (0.62%)  1/319 (0.31%) 
Abdominal pain * 1  1/322 (0.31%)  0/319 (0.00%) 
Inguinal hernia * 1  0/322 (0.00%)  1/319 (0.31%) 
Oesophageal spasm * 1  1/322 (0.31%)  0/319 (0.00%) 
Hepatobiliary disorders     
Any Hepatobiliary disorders * 1  1/322 (0.31%)  1/319 (0.31%) 
Cholecystitis acute * 1  0/322 (0.00%)  1/319 (0.31%) 
Cholelithiasis obstructive * 1  1/322 (0.31%)  0/319 (0.00%) 
Infections and infestations     
Any Infections and Infestations * 1  3/322 (0.93%)  1/319 (0.31%) 
Bronchitis * 1  1/322 (0.31%)  0/319 (0.00%) 
Genital abscess * 1  1/322 (0.31%)  0/319 (0.00%) 
Perianal abscess * 1  0/322 (0.00%)  1/319 (0.31%) 
Pyelonephritis chronic * 1  1/322 (0.31%)  0/319 (0.00%) 
Injury, poisoning and procedural complications     
Any Injury, Poisoning and Procedural Complications * 1  2/322 (0.62%)  1/319 (0.31%) 
Incisional hernia * 1  0/322 (0.00%)  1/319 (0.31%) 
Pelvic fracture * 1  1/322 (0.31%)  0/319 (0.00%) 
Traumatic ulcer * 1  1/322 (0.31%)  0/319 (0.00%) 
Investigations     
Any Investigations * 1  1/322 (0.31%)  0/319 (0.00%) 
Blood glucose increased * 1  1/322 (0.31%)  0/319 (0.00%) 
Metabolism and nutrition disorders     
Any Metabolism and nutrition disorders * 1  2/322 (0.62%)  0/319 (0.00%) 
Hypoglycaemia * 1  2/322 (0.62%)  0/319 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Any Neoplasms Benign, Malignant and Unspecified (Incl Cysts and Polyps) * 1  2/322 (0.62%)  0/319 (0.00%) 
Breast cancer * 1  1/322 (0.31%)  0/319 (0.00%) 
Rectal cancer * 1  1/322 (0.31%)  0/319 (0.00%) 
Nervous system disorders     
Any Nervous System Disorders * 1  0/322 (0.00%)  2/319 (0.63%) 
Headache * 1  0/322 (0.00%)  1/319 (0.31%) 
Syncope * 1  0/322 (0.00%)  1/319 (0.31%) 
Psychiatric disorders     
Any Psychiatric Disorders * 1  1/322 (0.31%)  1/319 (0.31%) 
Depression * 1  0/322 (0.00%)  1/319 (0.31%) 
Major depression * 1  1/322 (0.31%)  0/319 (0.00%) 
Reproductive system and breast disorders     
Any Reproductive System and Breast Disorders * 1  1/322 (0.31%)  0/319 (0.00%) 
Balanoposthitis * 1  1/322 (0.31%)  0/319 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Any Respiratory, Thoracic and Mediastinal Disorders * 1  0/322 (0.00%)  1/319 (0.31%) 
Asthma * 1  0/322 (0.00%)  1/319 (0.31%) 
Skin and subcutaneous tissue disorders     
Any Skin and Subcutaneous Tissue Disorders * 1  2/322 (0.62%)  0/319 (0.00%) 
Leukocytoclastic vasculitis * 1  1/322 (0.31%)  0/319 (0.00%) 
Skin ulcer * 1  1/322 (0.31%)  0/319 (0.00%) 
Vascular disorders     
Any Vascular Disorders * 1  1/322 (0.31%)  0/319 (0.00%) 
Extremity necrosis * 1  1/322 (0.31%)  0/319 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sitagliptin 100 mg q.d. Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   49/322 (15.22%)   25/319 (7.84%) 
Metabolism and nutrition disorders     
Any Metabolism and nutrition disorders * 1  49/322 (15.22%)  25/319 (7.84%) 
Hypoglycaemia * 1  49/322 (15.22%)  25/319 (7.84%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
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: NCT00395343     History of Changes
Other Study ID Numbers: 0431-051
MK0431-051
2006_532
First Submitted: November 1, 2006
First Posted: November 2, 2006
Results First Submitted: September 18, 2009
Results First Posted: October 23, 2009
Last Update Posted: May 12, 2017