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Clinical Trial Details

Trial ID: L5371
Source ID: NCT00767000
Associated Drug: Mk-0941
Title: Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00767000/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: MK-0941|DRUG: Comparator: Placebo|BIOLOGICAL: Lantus|DRUG: Metformin
Outcome Measures: Primary: Change in Hemoglobin A1c (HbA1c) Level, Least square means change from baseline in HbA1c. HbA1c represents the percentage of glycated hemoglobin. A negative number means reduction in HbA1c level., Baseline and Weeks 14, 54, 106, and 158|Percentage of Participants Who Experienced at Least One Adverse Event, Entire study including 54-week study and 104-week extension|Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event, Entire study including 54-week study and 104-week extension | Secondary: Change in the Two-hour Post Meal Glucose Level, Least squares mean change from baseline in 2-hour post meal glucose level., Baseline and Weeks 14, 54, 106, and 158|Change in the Fasting Plasma Glucose Level, Least squares mean change from baseline in fasting plasma glucose., Baseline and Weeks 14, 54, 106, and 158|Percentage of Participants Who Achieve an HbA1c of <7.0%, Weeks 106 and 158|Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%, Weeks 54, 106 and 158
Sponsor/Collaborators: Sponsor: Merck Sharp & Dohme LLC
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 813
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2008-10
Completion Date: 2010-06
Results First Posted: 2012-09-03
Last Update Posted: 2015-02-19
Locations:
URL: https://clinicaltrials.gov/show/NCT00767000