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Clinical Trial Details

Trial ID: L6379
Source ID: NCT01545388
Associated Drug: Sitagliptin
Title: Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01545388/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin|DRUG: Metformin|DRUG: Metformin|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c), Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups., Baseline and Week 24|Percentage of Participants Who Experienced at Least One Adverse Event, Up to 26 weeks|Number of Participants Who Discontinued Study Drug Due to an Adverse Event, Up to 24 weeks | Secondary: Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG), Based on a cLDA model with terms for treatment, other prior AHA therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 337
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-02-23
Completion Date: 2013-03-12
Results First Posted: 2014-03-26
Last Update Posted: 2018-08-22
Locations:
URL: https://clinicaltrials.gov/show/NCT01545388