The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be well-tolerated at 1 or more doses that demonstrate efficacy.
This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK-0941-007-11). Beginning on Week 16, participants not randomized to the maximum dose of MK-0941 could up-titrate to MK-0941 40 mg three times daily. Participants who complete the 54-week base study are eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
813
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.
Time frame: Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Experienced at Least One Adverse Event
Time frame: Entire study including 54-week study and 104-week extension
Percentage of Participants Who Discontinued Study Medication Due to an Adverse Event
Time frame: Entire study including 54-week study and 104-week extension
Change in the Two-hour Post Meal Glucose Level
Least squares mean change from baseline in 2-hour post meal glucose level.
Time frame: 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.
Time frame: Baseline and Weeks 14, 54, 106, and 158
Percentage of Participants Who Achieve an HbA1c of <7.0%
Time frame: Weeks 106 and 158
Percentage of Participants Achieving an HbA1c of <7.0% at Week 54 Who Maintain an HbA1c of <7.0%
Time frame: Weeks 54, 106 and 158
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Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.