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Clinical Trial Details

Trial ID: L4957
Source ID: NCT00395343
Associated Drug: Sitagliptin Phosphate
Title: Sitagliptin Added-on to Insulin Study (0431-051)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00395343/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: sitagliptin phosphate|DRUG: Comparator : placebo (unspecified)
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., Baseline and Week 24 | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Baseline and Week 24|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24, Change from baseline at Week 24 is defined as Week 24 minus Week 0., Baseline and Week 24|Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24, 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. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.), Baseline and Week 24|Percent of Patients With A1C < 7.0% at Week 24, 24 Weeks|Percent of Patients With A1C < 6.5% at Week 24, Week 24 | Other: Change From Baseline in A1C at Week 24, A1C in subset of patients on long-acting or intermediate-acting insulin. A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 641
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-12-11
Completion Date: 2008-10-13
Results First Posted: 2009-10-23
Last Update Posted: 2017-05-12
Locations:
URL: https://clinicaltrials.gov/show/NCT00395343