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Clinical Trial Details

Trial ID: L1989
Source ID: NCT00830076
Associated Drug: Sitagliptin Phosphate
Title: A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00830076/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: sitagliptin phosphate|DRUG: metformin hydrochloride|DRUG: Comparator: placebo sitagliptin|DRUG: Comparator: placebo metformin
Outcome Measures: Primary: Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations, Meal was given 2 hours postdose. Blood samples for determination of active GLP-1 concentration were collected (4 hours postmeal) on Day 2 in each treatment period., 6 hours postdose (4 hours postmeal) on Day 2 | Secondary: β-cell Sensitivity, β-cell sensitivity was defined as the incremental post-prandial 4-hour area under the curve (AUC) for insulin secretion rate (ISR) normalized by the incremental post-prandial 4-hour plasma glucose AUC., 6 hour post-dose (4 hour postmeal) on Day 2|Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations, Meal was given 2 hours postdose. Blood samples for determination of glucose concentration were collected (4 hours postmeal) on Day 2 in each treatment period., 6 hours postdose (4 hours postmeal) on Day 2
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-12-02
Completion Date: 2009-05-14
Results First Posted: 2011-11-03
Last Update Posted: 2017-05-15
Locations:
URL: https://clinicaltrials.gov/show/NCT00830076