Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2851
Source ID: NCT00511472
Associated Drug: Mk-0941
Title: An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00511472/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: MK-0941|DRUG: Placebo|DRUG: LANTUS insulin
Outcome Measures: Primary: Number of Participants Who Experienced an Adverse Event During the Study, 39 days | Secondary: Number of Participants Who Experienced an Adverse Event - Titration Scheme 1, In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose \[TD\] Days 1 to 4 of the Titration Phase 1 of the study., 25 days|Number of Participants Who Experienced an Adverse Event - Titration Scheme 2, Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration., 25 days|24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7, Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7., 24 hours|Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period, During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home., Outpatient Days 1 to 14
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-07
Completion Date: 2008-04
Results First Posted: 2012-07-11
Last Update Posted: 2015-07-15
Locations:
URL: https://clinicaltrials.gov/show/NCT00511472