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Study to Evaluate the Safety and Efficacy of the Addition of Omarigliptin (MK-3102) Compared With the Addition of Sitagliptin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-3102-026)

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ClinicalTrials.gov Identifier: NCT01841697
Recruitment Status : Completed
First Posted : April 26, 2013
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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 2 Diabetes
Interventions Drug: Omarigliptin
Drug: Sitagliptin
Drug: Placebo to omarigliptin
Drug: Placebo to Sitagliptin
Drug: Open-label Metformin
Drug: Open-label Glimepiride
Enrollment 642

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy. Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Period Title: Overall Study
Started 322 320
Completed 302 302
Not Completed 20 18
Reason Not Completed
Death             0             1
Lost to Follow-up             4             1
Withdrawal by Subject             16             16
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily Total
Hide Arm/Group Description Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy. Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy. Total of all reporting groups
Overall Number of Baseline Participants 322 320 642
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 322 participants 320 participants 642 participants
57.0  (9.8) 57.6  (9.8) 57.3  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants 320 participants 642 participants
Female
171
  53.1%
145
  45.3%
316
  49.2%
Male
151
  46.9%
175
  54.7%
326
  50.8%
Hemoglobin A1c (A1C)  
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 322 participants 320 participants 642 participants
7.52  (0.77) 7.49  (0.74) 7.50  (0.76)
Fasting plasma glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 322 participants 320 participants 642 participants
160.1  (35.7) 153.9  (32.8) 157.0  (34.4)
1.Primary Outcome
Title Change From Baseline in A1C at Week 24
Hide Description A1C is a measure of the percentage of glycated hemoglobin in the blood. Participant whole blood samples were collected at baseline and Week 24 to determine the least squares mean A1C change from baseline.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description:
Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Number of Participants Analyzed 322 320
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Percent
-0.47
(-0.55 to -0.38)
-0.43
(-0.51 to -0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg Once Weekly, Sitagliptin 100 mg Once Daily
Comments Constrained longitudinal data analysis
Type of Statistical Test Non-Inferiority or Equivalence
Comments If the upper bound of the two-sided 95% confidence interval for the mean difference between omarigilptin and sitagliptin is less than the non-inferiority margin, δ =0.3%, then omarigliptin will be declared non-inferior to sitagliptin in terms of A1C reduction at Week 24.
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value -0.03
Confidence Interval (2-Sided) 95%
-0.15 to 0.08
Estimation Comments Difference is omarigliptin minus sitagliptin.
2.Primary Outcome
Title Percentage of Participants Who Experienced at Least One Adverse Event
Hide Description An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
Time Frame Up to 27 weeks (including 3-week follow-up)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description:
Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Number of Participants Analyzed 322 320
Measure Type: Number
Unit of Measure: Percentage of participants
36.3 40.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg Once Weekly, Sitagliptin 100 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percent
Estimated Value -4.3
Confidence Interval (2-Sided) 95%
-11.8 to 3.2
Estimation Comments Difference is omarigliptin minus sitagliptin.
3.Primary Outcome
Title Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event
Hide Description An adverse event is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an adverse event. Data presented below excludes data after initiation of glycemic rescue therapy.
Time Frame Up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants as treated population consists of all randomized participants who received at least one dose of trial treatment. Participants are included in the treatment group corresponding to the trial treatment they actually received.
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description:
Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Number of Participants Analyzed 322 320
Measure Type: Number
Unit of Measure: Percentage of participants
0.9 2.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg Once Weekly, Sitagliptin 100 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percent
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-3.6 to 0.8
Estimation Comments Difference is omarigliptin minus sitagliptin.
4.Secondary Outcome
Title Change From Baseline in FPG at Week 24
Hide Description Participant whole blood samples were collected after an overnight fast at baseline and Week 24 to determine the least squares mean change from baseline in participant FPG.
Time Frame Baseline and Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description:
Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Number of Participants Analyzed 322 320
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-13.7
(-17.3 to -10.1)
-9.5
(-13.2 to -5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg Once Weekly, Sitagliptin 100 mg Once Daily
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.089
Comments [Not Specified]
Method Constrained logitudinal data analysis
Comments Terms for treatment, time, and the interaction of time by treatment, with the constraint that the mean baseline is the same for all treatment groups.
Method of Estimation Estimation Parameter Difference in least squares mean
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-9.0 to 0.6
Estimation Comments Difference is omarigliptin minus sitagliptin.
5.Secondary Outcome
Title Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment
Hide Description Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C <7.0% at Week 24.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description:
Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Number of Participants Analyzed 322 320
Measure Type: Number
Unit of Measure: Percentage of participants
50.9 49.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg Once Weekly, Sitagliptin 100 mg Once Daily
Comments Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.619
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Between-group rate difference
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-5.9 to 9.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment
Hide Description Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C <6.5% at Week 24.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis set population consists of all randomized participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint subsequent to at least one dose of study treatment.
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description:
Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
Overall Number of Participants Analyzed 322 320
Measure Type: Number
Unit of Measure: Percentage of participants
27.0 22.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Omarigliptin 25 mg Once Weekly, Sitagliptin 100 mg Once Daily
Comments Proportion (rate) for each group was estimated using standard multiple imputation techniques. Between-group difference in proportion is omarigliptin minus sitagliptin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.212
Comments [Not Specified]
Method Miettinen & Nurminen method
Comments [Not Specified]
Method of Estimation Estimation Parameter Between-group rate difference
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
-2.5 to 11.4
Estimation Comments [Not Specified]
Time Frame Up to 27 weeks (including 3-week follow-up)
Adverse Event Reporting Description All participants as treated population defined as all randomized participants who received at least 1 dose of study drug. Participants are included in the treatment group corresponding to the trial treatment they actually received. Serious and non-serious AEs, respectively, include and exclude data after the initiation of glycemic rescue therapy.
 
Arm/Group Title Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Hide Arm/Group Description Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy. Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
All-Cause Mortality
Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/322 (3.42%)      9/320 (2.81%)    
Cardiac disorders     
Acute myocardial infarction  1  1/322 (0.31%)  1 1/320 (0.31%)  1
Angina pectoris  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Arrhythmia supraventricular  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Atrial fibrillation  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Myocardial infarction  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Myocardial ischaemia  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Endocrine disorders     
Hypothyroidism  1  1/322 (0.31%)  1 0/320 (0.00%)  0
General disorders     
Non-cardiac chest pain  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Cholelithiasis  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Infections and infestations     
Pyelonephritis acute  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Non-small cell lung cancer  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Prostate cancer  1  2/322 (0.62%)  2 0/320 (0.00%)  0
Sebaceous adenoma  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Nervous system disorders     
Cerebrovascular disorder  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Diabetic neuropathy  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Ischaemic stroke  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Dyspnoea  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Skin and subcutaneous tissue disorders     
Dematitis contact  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Psoriasis  1  1/322 (0.31%)  1 0/320 (0.00%)  0
Vascular disorders     
Hypertension  1  0/322 (0.00%)  0 1/320 (0.31%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Omarigliptin 25 mg Once Weekly Sitagliptin 100 mg Once Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/322 (0.00%)      0/320 (0.00%)    
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
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01841697     History of Changes
Other Study ID Numbers: 3102-026
2013-000059-42 ( EudraCT Number )
First Submitted: April 24, 2013
First Posted: April 26, 2013
Results First Submitted: October 23, 2015
Results First Posted: November 25, 2015
Last Update Posted: September 10, 2018