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Clinical Trial Details

Trial ID: L3521
Source ID: NCT00813995
Associated Drug: Comparator: Sitagliptin Phosphate
Title: A Study to Test the Safety and Efficacy of Adding Sitagliptin in Patients With Type 2 Diabetes Mellitus (MK0431-074)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00813995/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Comparator: Sitagliptin phosphate|DRUG: Comparator: Placebo
Outcome Measures: Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent., Baseline and Week 24 | Secondary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1000 mg/Day, A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent., Baseline and Week 24|Change From Baseline in Hemoglobin A1c (A1C) at Week 24 for Participants on Metformin 1700 mg/Day, A1C is measured as percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent., Baseline and Week 24|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Baseline and Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 395
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-12-09
Completion Date: 2010-08-09
Results First Posted: 2011-09-13
Last Update Posted: 2017-05-12
Locations:
URL: https://clinicaltrials.gov/show/NCT00813995