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Clinical Trial Details

Trial ID: L6226
Source ID: NCT01755156
Associated Drug: Omarigliptin
Title: A Study to Evaluate the Safety, Tolerability, and Efficacy of the Addition of Omarigliptin (MK-3102) to Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy (MK-3102-024)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01755156/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Omarigliptin|DRUG: Matching placebo to omarigliptin|DRUG: Glimepiride|DRUG: Matching placebo to glimepiride|DRUG: Insulin glargine|DRUG: Metformin
Outcome Measures: Primary: Change From Baseline in Glycosylated Hemoglobin (A1C) at Week 24 (Phase A), A1C is measured as a percent. Change from baseline in A1C at Week 24 was analyzed using a constrained longitudinal data analysis (cLDA) method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment., Baseline and Week 24|Percentage of Participants Who Experienced at Least One Adverse Event (Phase A+B), An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue., Up to 107 weeks|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (Phase A+B), An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Presented data exclude data after glycemic rescue., Up to 104 weeks|Percentage of Participants Who Experienced an Adverse Event Which Were Included Under the System Order Class of Investigations (Phase A+B), The following laboratory parameters were included: blood chemistry, hematology, electrocardiograms, lipids, body weight, and vital signs., Up to 104 weeks | Secondary: Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 (Phase A), Change from baseline in 2-hour PMG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment., Baseline and Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A), Change from baseline in FPG at Week 24 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment., Baseline and Week 24|Change From Baseline in A1C at Week 104 (Phase A+B), A1C is measured as a percent. Change from baseline in A1C at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment., Baseline and Week 104|Change From Baseline in FPG at Week 104 (Phase A+B), Change from baseline in FPG at Week 104 was analyzed using cLDA method with a restriction of the same baseline mean across treatment groups. The cLDA model included terms for treatment, time, and the interaction of time by treatment., Baseline and Week 104|Percentage of Participants Attaining A1C Glycemic Goals of <7.0% After 24 Weeks of Treatment (Phase A), Percentage of participants attaining A1C glycemic goals of \<7.0% (53 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques., 24 weeks|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 24 Weeks of Treatment (Phase A), Percentage of participants attaining A1C glycemic goals of \<6.5% (48 mmol/mol) after 24 weeks of treatment estimated using standard multiple imputation techniques., 24 weeks|Percentage of Participants Attaining A1C Glycemic Goals of <7% After 104 Weeks of Treatment (Phase A+B), Percentage of participants attaining A1C glycemic goals of \<7.0% (53 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques., 104 weeks|Percentage of Participants Attaining A1C Glycemic Goals of <6.5% After 104 Weeks of Treatment (Phase A+B), Percentage of participants attaining A1C glycemic goals of \<6.5% (48 mmol/mol) after 104 weeks of treatment estimated using standard multiple imputation techniques., 104 weeks|Change From Baseline in PMG Total Area Under the Plasma Concentration Time Curve (AUC) at Week 24 (Phase A), Change from baseline in PMG total AUC at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment. Plasma glucose levels were measured before the meal (0 minutes), and at 60 and 120 minutes after the meal., Baseline and Week 24|Change From Baseline in Fasting Insulin at Week 24 (Phase A), Change from baseline in fasting insulin at Week 24 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment., Baseline and Week 24|Change From Baseline in Fasting Insulin at Week 104 (Phase A+B), Change from baseline in fasting insulin at Week 104 based on a cLDA model including terms for treatment, time, and the interaction of time by treatment., Baseline and Week 104|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 24 Weeks (Phase A), Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride., Up to 24 weeks|Kaplan-Meier Estimate of Cumulative Incidence of Participants Requiring Glycemic Rescue Therapy by 104 Weeks (Phase A+B), Participants who did not meet progressively stricter glycemic criteria in Phase A had rescue initiated with open-label glimepiride. If during Phase B participants on open-label glimepiride or blinded glimepiride/glimepiride matching placebo needed rescue after maximum up-titration, then insulin glargine was initiated and the dose of open-label glimepiride or blinded glimepiride/glimepiride-matching placebo was discontinued., Up to 104 weeks|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 24 (Phase A), Data presented are a cumulative incidence of participants with glycemic rescue by Week 24., Up to 24 weeks|Percentage of Participants Requiring Glycemic Rescue Therapy at or Before Week 104 (Phase A+B), Data presented are a cumulative incidence of participants with glycemic rescue by Week 104., Up to 104 weeks
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 402
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-01-11
Completion Date: 2016-03-16
Results First Posted: 2017-03-20
Last Update Posted: 2018-09-10
Locations:
URL: https://clinicaltrials.gov/show/NCT01755156