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Clinical Trial Details

Trial ID: L5160
Source ID: NCT00350779
Associated Drug: Sitagliptin
Title: Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00350779/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: sitagliptin|DRUG: Comparator: Placebo|DRUG: rosiglitazone|DRUG: metformin|DRUG: glipizide
Outcome Measures: Primary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 18, HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 18 HbA1c percent minus the Week 0 HbA1c percent., Baseline and 18 Weeks | Secondary: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 18, Change from baseline at Week 18 is defined as Week 18 minus Week 0, Baseline and 18 Weeks|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 18, Change from baseline at Week 18 is defined as Week 18 minus Week 0, Baseline and Week 18|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54, HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent., Baseline and Week 54|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54, Change from baseline at Week 54 is defined as Week 54 minus Week 0, Baseline and Week 54|Change From Baseline in 2-hour PMG (Post-meal Glucose) at Week 54, Change from baseline at Week 54 is defined as Week 54 minus Week 0., Baseline and Week 54
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 262
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-06-12
Completion Date: 2008-06-11
Results First Posted: 2009-07-03
Last Update Posted: 2017-05-12
Locations:
URL: https://clinicaltrials.gov/show/NCT00350779