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Clinical Trial Details

Trial ID: L6876
Source ID: NCT01841697
Associated Drug: Omarigliptin
Title: 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)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01841697/results
Conditions: Type 2 Diabetes
Interventions: DRUG: Omarigliptin|DRUG: Sitagliptin|DRUG: Placebo to omarigliptin|DRUG: Placebo to Sitagliptin|DRUG: Open-label Metformin|DRUG: Open-label Glimepiride
Outcome Measures: Primary: Change From Baseline in A1C at Week 24, 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., Baseline and Week 24|Percentage of Participants Who Experienced at Least One Adverse Event, 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., Up to 27 weeks (including 3-week follow-up)|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event, 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., Up to 24 weeks | Secondary: Change From Baseline in FPG at Week 24, 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., Baseline and Week 24|Percentage of Participants Achieving an A1C Goal <7.0% After 24 Weeks of Treatment, Participant whole blood samples were collected at Week 24 to determine the number of participants achieving A1C \<7.0% at Week 24., Week 24|Percentage of Participants Achieving an A1C Goal <6.5% After 24 Weeks of Treatment, Participant whole blood samples were collected at Week 24 to determine the percentage of participants achieving A1C \<6.5% at Week 24., Week 24
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 642
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2013-06-13
Completion Date: 2014-11-17
Results First Posted: 2015-11-25
Last Update Posted: 2018-09-10
Locations:
URL: https://clinicaltrials.gov/show/NCT01841697