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Clinical Trial Details

Trial ID: L1859
Source ID: NCT00103857
Associated Drug: Comparator: Mk0431 50 Mg B.i.d. (B.i.d. = Twice Daily)
Title: MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00103857/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)|DRUG: Comparator: MK0431 100 mg q.d. (q.d. = once daily)|DRUG: Comparator: Placebo (Phase A)/Metformin (Phase B)|DRUG: Comparator: Metformin 500 mg b.i.d.|DRUG: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.|DRUG: Comparator: Metformin 1000 mg b.i.d.
Outcome Measures: Primary: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24, HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent., Week 24 | Secondary: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Week 24|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Week 24|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54, HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent., 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., 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., Week 54|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104, HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent., Week 104|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104, Change from baseline at Week 104 is defined as Week 104 minus Week 0., Week 104|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104, Change from baseline at Week 104 is defined as Week 104 minus Week 0., Week 104
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1208
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2005-03-17
Completion Date: 2008-02-21
Results First Posted: 2009-05-19
Last Update Posted: 2017-05-05
Locations:
URL: https://clinicaltrials.gov/show/NCT00103857

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