Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4888
Source ID: NCT01582308
Associated Drug: Sitagliptin 100 Mg
Title: A Study Comparing the Pharmacokinetic and Pharmacodynamic Profiles for Sitagliptin, Saxagliptin and Vildagliptin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-142)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01582308/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Sitagliptin 100 mg|DRUG: Saxagliptin 5 mg|DRUG: Vildagliptin 50 mg|DRUG: Vildagliptin 50 mg BID|DRUG: Placebo
Outcome Measures: Primary: Percent Inhibition of Dipeptidyl Peptidase IV (DPP-4) Activity at Trough, Percent inhibition of DPP-4 activity at 24 hours after the Day 5 morning dose (i.e., at trough) was determined by analysis of blood samples collected from the study participants., 24 hours following the final morning dose on Day 5 | Secondary: Pharmacokinetic Analysis: Area Under the Curve 0-24 Hours (AUC 0-24hr), AUC 0-24hr is the area under the plasma drug concentration-time curve calculated for the 24 hour interval after the Day 5 morning dose., Predose (0 Hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20 and 24 hours after the morning dose on Day 5|Pharmacokinetic Analysis: Area Under the Curve 0-12 Hours (AUC 0-12hr) for Vildagliptin 50 mg BID, AUC 0-12hr is the area under the plasma drug concentration-time curve calculated for the 12 hour interval after the Day 5 morning dose for the vildagliptin 50 mg BID dose only., Predose (0 hours) and 0.5, 1, 2, 4, 8 and 12 hours after the morning dose on Day 5|Pharmacokinetic Analysis: Peak Plasma Drug Concentration (Cmax), Measurement of the peak plasma drug concentration following the Day 5 morning dose., Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5|Pharmacokinetic Analysis: Time to the Peak Plasma Drug Concentration (Tmax), Measurement of the time to the peak plasma drug concentration following the Day 5 morning dose., Predose (0 hours) and 0.5, 1, 2, 4, 8, 12, 13 (vildagliptin 50 mg BID only), 14 (vildagliptin 50 mg BID only), 16, 20, 24, 36, 48 and 96 hours after the morning dose on Day 5
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 22
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-06-21
Completion Date: 2012-12-14
Results First Posted: 2014-01-22
Last Update Posted: 2017-05-30
Locations:
URL: https://clinicaltrials.gov/show/NCT01582308