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Clinical Trial Details

Trial ID: L6669
Source ID: NCT01704261
Associated Drug: Omarigliptin
Title: 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)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01704261/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Omarigliptin|DRUG: Matching placebo to Omarigliptin|DRUG: Glimepiride|DRUG: Metformin
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, 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., Baseline and Week 24|Percentage of Participants Who Experienced at Least One Adverse Event (AE), 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., Up to Week 27|Percentage of Participants Who Discontinued From the Study Due to an AE, 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., Up to Week 24 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, 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)., Baseline and Week 24|Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% at Week 24, 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., 24 weeks
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 307
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-10-18
Completion Date: 2014-12-23
Results First Posted: 2015-11-25
Last Update Posted: 2018-09-10
Locations:
URL: https://clinicaltrials.gov/show/NCT01704261