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Clinical Trial Details

Trial ID: L4199
Source ID: NCT00087516
Associated Drug: Sitagliptin (Mk0431)
Title: Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00087516/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Sitagliptin (MK0431)|DRUG: Sitagliptin|DRUG: Placebo|DRUG: Placebo|DRUG: Metformin - Rescue
Outcome Measures: Primary: Change From Baseline in A1C at Week 24, A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent., Weeks 0-24 | Secondary: Change From Baseline in FPG at Week 24, Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG., Weeks 0-24|Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24, Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG., Weeks 0-24|Change From Baseline in A1C at Week 104, A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent., Weeks 0-104|Change From Baseline in FPG at Week 104, Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG., Weeks 0-104|Change From Baseline in 2-hr PMG at Week 104, Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG., Weeks 0-104
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 741
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2004-06
Completion Date: 2007-02
Results First Posted: 2010-06-08
Last Update Posted: 2015-07-03
Locations:
URL: https://clinicaltrials.gov/show/NCT00087516

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details