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Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Combination Therapy With Glimepiride and Metformin (MK-3102-022)

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ClinicalTrials.gov Identifier: NCT01704261
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : November 25, 2015
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Type 2 Diabetes Mellitus
Interventions Drug: Omarigliptin
Drug: Matching placebo to Omarigliptin
Drug: Glimepiride
Drug: Metformin
Enrollment 307
Recruitment Details Fifty-one sites received IEC/IRB approval and were shipped clinical supplies.
Pre-assignment Details In total, 583 participants were screened and 276 participants were excluded during screening. The most common reason for participants not being randomized was screen failure. The most common reasons for screen failure were not meeting the metformin and glimepiride dose requirements inclusion criterion or meeting exclusionary laboratory values.
Arm/Group Title Omarigliptin Placebo
Hide Arm/Group Description Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Period Title: Overall Study
Started 154 153
Completed 141 138
Not Completed 13 15
Reason Not Completed
Withdrawal by Subject             12             15
Lost to Follow-up             1             0
Arm/Group Title Omarigliptin Placebo Total
Hide Arm/Group Description Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). Total of all reporting groups
Overall Number of Baseline Participants 154 153 307
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 153 participants 307 participants
57.2  (8.4) 58.4  (9.4) 57.8  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 153 participants 307 participants
Female
81
  52.6%
79
  51.6%
160
  52.1%
Male
73
  47.4%
74
  48.4%
147
  47.9%
1.Primary Outcome
Title Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Hide Description A1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Thus, this change from baseline reflects the Week 24 A1C minus the Week 0 A1C.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.
Arm/Group Title Omarigliptin Placebo
Hide Arm/Group Description:
Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Overall Number of Participants Analyzed 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: %A1C
-0.67
(-0.84 to -0.50)
-0.06
(-0.23 to 0.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin, 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 Difference in the least squares means
Comments Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.85 to -0.38
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Hide Description An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Time Frame Up to Week 27
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects as Treated (ASaT) population, defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.
Arm/Group Title Omarigliptin Placebo
Hide Arm/Group Description:
Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Overall Number of Participants Analyzed 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
57.5 47.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % Omarigliptin vs Placebo
Estimated Value 9.8
Confidence Interval (2-Sided) 95%
-1.4 to 20.8
Estimation Comments [Not Specified]
3.Primary Outcome
Title Percentage of Participants Who Discontinued From the Study Due to an AE
Hide Description An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ASaT Population was defined as all randomized participants who received at least 1 dose of study medication. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.
Arm/Group Title Omarigliptin Placebo
Hide Arm/Group Description:
Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Overall Number of Participants Analyzed 153 153
Measure Type: Number
Unit of Measure: Percentage of participants
2.6 2.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in % Omarigliptin vs Placebo
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4.3 to 4.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Hide Description Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.
Arm/Group Title Omarigliptin Placebo
Hide Arm/Group Description:
Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Overall Number of Participants Analyzed 153 153
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-19.6
(-26.7 to -12.5)
-3.0
(-10.2 to 4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin, 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 Difference in the least squares means
Comments Based on a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups.
Method of Estimation Estimation Parameter Difference of the least squares means
Estimated Value -16.6
Confidence Interval (2-Sided) 95%
-25.5 to -7.8
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24
Hide Description The percentage of participants who achieved A1C values <6.5% (48 mmol/mol) or <7.0% (53 mmol/mol) in the FAS population at Week 24.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS Population consisted of all randomized participants who received at least 1 dose of study medication and had a baseline measurement or a measurement for the analysis endpoint after receiving study medication. One participant was in 2 clinical trials in parallel and was excluded from all efficacy and safety analysis.
Arm/Group Title Omarigliptin Placebo
Hide Arm/Group Description:
Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
Overall Number of Participants Analyzed 153 153
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
<7.0%
23.8
(17.5 to 31.5)
4.4
(2.1 to 9.3)
<6.5%
10.1
(6.1 to 16.4)
2.1
(0.7 to 6.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin, 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 Miettinen & Nurminen method
Comments Between-group confidence intervals and p-value (%) A1C <7.0%; estimated using standard multiple imputation techniques.
Method of Estimation Estimation Parameter Between-group Rate Difference
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
11.7 to 27.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Omarigliptin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments Between-group confidence intervals and p-value (%) A1C <7.0%; estimated using standard multiple imputation techniques.
Method of Estimation Estimation Parameter Between-group Rate Difference (%)
Estimated Value 8.0
Confidence Interval (2-Sided) 95%
2.7 to 14.5
Estimation Comments [Not Specified]
Time Frame Up to Week 27
Adverse Event Reporting Description The ASaT Population was all randomized participants who received at least one study drug. Participants were included in the treatment group corresponding to the study treatment they actually received. One participant was in 2 clinical trials and was excluded from all efficacy and safety analysis.
 
Arm/Group Title Omarigliptin Placebo
Hide Arm/Group Description Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day). Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
All-Cause Mortality
Omarigliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Omarigliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/153 (1.96%)      5/153 (3.27%)    
Ear and labyrinth disorders     
Vertigo  1  1/153 (0.65%)  1 0/153 (0.00%)  0
Gastrointestinal disorders     
Duodenal ulcer haemorrhage  1  0/153 (0.00%)  0 1/153 (0.65%)  1
Oesophagitis  1  0/153 (0.00%)  0 1/153 (0.65%)  1
Pancreatitis  1  0/153 (0.00%)  0 1/153 (0.65%)  1
General disorders     
Non-cardiac chest pain  1  1/153 (0.65%)  1 0/153 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/153 (0.65%)  1 0/153 (0.00%)  0
Injury, poisoning and procedural complications     
Road traffic accident  1  0/153 (0.00%)  0 1/153 (0.65%)  1
Nervous system disorders     
Cerebrovascular accident  1  0/153 (0.00%)  0 1/153 (0.65%)  1
Cerebrovascular disorder  1  1/153 (0.65%)  1 0/153 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omarigliptin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/153 (18.95%)      23/153 (15.03%)    
Infections and infestations     
Upper respiratory tract infection  1  4/153 (2.61%)  4 9/153 (5.88%)  11
Urinary tract infection  1  9/153 (5.88%)  9 3/153 (1.96%)  4
Metabolism and nutrition disorders     
Hypoglycaemia  1  18/153 (11.76%)  65 13/153 (8.50%)  44
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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 trial 45 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
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: NCT01704261    
Other Study ID Numbers: 3102-022
2012-002612-10 ( EudraCT Number )
First Submitted: October 8, 2012
First Posted: October 11, 2012
Results First Submitted: October 23, 2015
Results First Posted: November 25, 2015
Last Update Posted: September 10, 2018