Logo 1 Logo 2

Clinical Trial Details

Trial ID: L3276
Source ID: NCT02004886
Associated Drug: Mk-0893
Title: A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02004886/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: MK-0893|DRUG: Metformin|DRUG: Placebo|DRUG: Placebo
Outcome Measures: Primary: Change From Baseline in 24-hour Weighted Mean Glucose (WMG) at Week 4, Blood samples were collected 30 minutes prior to all meals, and 15, 30, 60, 90, 120, 180 minutes post-meal, then and at midnight, 3 AM, and the next morning at 6:30 AM and 7:30 AM. A 24-hour weighted mean glucose (WMG) was determined by averaging multiple plasma glucose measurements over a 24-hour period., Baseline and Week 4|Number of Participants Experiencing an Adverse Event (AE), An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product., Up to 42 days|Number of Participants Discontinuing Study Treatment Due to an AE, An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product., Up to 28 days | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG), Plasma Glucose levels were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value., Baseline and Week 4|Change From Baseline in Fructosamine at Week 4, Fructosamine levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value., Baseline and Week 4|Change From Baseline in Fasting C-peptide at Week 4, Fasting C-peptide levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value., Baseline and Week 4|Change From Baseline in Fasting Insulin at Week 4, Fasting insulin levels in the blood were measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value., Baseline and Week 4|Change From Baseline in 2-hour Post-prandial Glucose Excursion at Week 4, 2-hour post-prandial glucose excursion is the change in glucose concentration in the blood 2 hours after a meal. Change from baseline in 2-hour post-prandial glucose excursion at Week 4 is defined as Week 4 minus baseline., Baseline and Week 4|Change From Baseline in 3-hour Area Under the Plasma Concentration Versus Time Curve (AUC) for Glucose at Week 4, Blood samples collected for glucose 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for Glucose was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value., Baseline and Week 4|Change From Baseline in 3-hour AUC for C-peptide at Week 4, Blood samples were collected for C-peptide 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour AUC for C-peptide was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value., Baseline and Week 4|Change From Baseline in 3-hour Insulin Total AUC at Week 4, Blood samples were collected for insulin 30 minutes prior to the breakfast meal and 15, 30, 60, 90, 120, 180 minutes post-meal. AUC is a measure of the amount of drug in the blood over time. 3-hour Insulin Total AUC was measured at Baseline and at Week 4. The change from baseline was defined as the Week 4 value minus the Baseline value., Baseline and Week 4
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 74
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2006-08-11
Completion Date: 2007-02-07
Results First Posted: 2014-03-18
Last Update Posted: 2018-09-05
Locations:
URL: https://clinicaltrials.gov/show/NCT02004886