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Clinical Trial Details

Trial ID: L2065
Source ID: NCT01640873
Associated Drug: Mk-8655
Title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8655 in Participants With Type 2 Diabetes (MK-8655-002)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01640873/results
Conditions: Type 2 Diabetes
Interventions: DRUG: MK-8655|DRUG: Placebo
Outcome Measures: Primary: Number of Participants With One or More Adverse Events, An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 14 days after the last dose of study drug (Up to 31 days)|Number of Participants Discontinuing Study Drug Due to an Adverse Event, An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study., Up to 17 days|Fasting Plasma Glucose (FPG), Blood for fasting plasma glucose (central laboratory) was obtained after at least 10 hours overnight fast., Day 16 (Predose) | Secondary: True Geometric Mean Plasma Concentrations of MK-8655 After Single and Multiple Drug Doses at 24 Hours Post Dose (C24), C24hr was log transformed and analyzed based on a linear mixed effects model containing fixed effects for treatment, day and treatment by day interaction and a random effect for the participant., 24 hours post dose on Days 1, 7, and 14|24-Hour Weighted Mean Glucose (WMG), The WMG provides an integrated assessment of the glycemic exposure over the 24-hour period. To reduce variability of the baseline (before any study drug administration) WMG, participants were domiciled in the test facility at least 36 hours prior to Day 1, where standard meals were provided, and physical activity was monitored. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The sample scheme for the 18 point glucose measurements used in this study had many samples taken in the very early morning hours, as well as the first three hours after meals. WMG was calculated as the area under the curve (AUC) of the glucose concentrations divided by the duration of time of samples collected., Day 15: Predose, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 18, 21, 23 hours post-dose.|Change From Baseline at 2 Hours Oral Glucose Tolerance Test, Plasma glucose excursion was assessed during an oral glucose tolerance test (oGTT) following a single dose administration of MK-8655 in participants with T2DM., Baseline and 2 hours after dosing on Days 1, 3, and 16
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 33
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-09-19
Completion Date: 2012-12-20
Results First Posted: 2018-11-13
Last Update Posted: 2018-11-13
Locations:
URL: https://clinicaltrials.gov/show/NCT01640873