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Clinical Trial Details

Trial ID: L6989
Source ID: NCT01088711
Associated Drug: Omarigliptin
Title: Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01088711/results
Conditions: Type 2 Diabetes (T2D)
Interventions: DRUG: Omarigliptin|DRUG: Placebo
Outcome Measures: Primary: Number of Participants Experiencing an Adverse Event (AE), Up to Day 36|Number of Participants Withdrawing From Study Therapy Due to an AE, Up to Day 22 | Secondary: Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15, Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline \[pre-dose on Day 1\]) was compared in healthy and T2D participants receiving omarigliptin or placebo., 168 hours post-dose on Day 15|Percent Inhibition of DPP-4 After Day 22, Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline \[pre-dose on Day 1\]) was compared in healthy and T2D participants receiving omarigliptin or placebo., 168 hours post dose on Day 22|WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration, Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means., Through 4 hours post dose on Day 21|WAA Total GLP-1 Concentration, WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means., Through 4 hours post dose on Day 21|Plasma Glucose Concentration, Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means., Through 4 hours post dose on Day 21
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-03-11
Completion Date: 2010-05-11
Results First Posted: 2015-12-24
Last Update Posted: 2018-09-10
Locations:
URL: https://clinicaltrials.gov/show/NCT01088711