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Clinical Trial Details

Trial ID: L4881
Source ID: NCT00511108
Associated Drug: Comparator: Sitagliptin Phosphate
Title: Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00511108/results
Conditions: Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: Comparator: sitagliptin phosphate|DRUG: Comparator: pioglitazone|DRUG: Comparator: placebo to pioglitazone|DRUG: Comparator: placebo to sitagliptin
Outcome Measures: Primary: Change From Baseline in Glucagon 3-hour Total Area Under the Curve (AUC) After 12 Weeks of Treatment, Glucagon concentration was measured at 9 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, and 180 minutes. Total AUC was calculated over 3 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC., Baseline and 12 weeks|Percent Change From Baseline in Index of Static Beta-cell Sensitivity to Glucose After 12 Weeks of Treatment, Static sensitivity is a measure of the effect of glucose on beta cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. Percent change from baseline was calculated as the difference between index of static sensitivities at Week 12 and at baseline with respect to the index of static sensitivity at baseline times 100., Baseline and 12 weeks | Secondary: Change From Baseline in Glucose 5-hour Total AUC After 12 Weeks of Treatment, Glucose concentration was measured at 11 points during an Meal Tolerance Test (MTT), at times -10, 0, 10, 20, 30, 60, 90, 120, 180, 240, 300 minutes. Total AUC was calculated over 5 hours including all sample points starting from 0 minutes using the trapezoid method. The change from baseline reflects Week 12 total AUC minus the Week 0 total AUC., Baseline and 12 weeks
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 211
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-07-11
Completion Date: 2009-02-24
Results First Posted: 2010-03-05
Last Update Posted: 2017-05-12
Locations:
URL: https://clinicaltrials.gov/show/NCT00511108