A Phase IIa, Multicenter, Double-Blind, Randomized, Active-Controlled, Parallel-Arm Clinical Trial to Study the Efficacy and Safety of MK-0941 Compared to Sulfonylurea in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy
Overview
- Phase
- Phase 2
- Intervention
- MK-0941
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 143
- Primary Endpoint
- Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has type 2 diabetes mellitus
- •Between the ages of 18 and 70
Exclusion Criteria
- •Patient has a history of type 1 diabetes mellitus or ketoacidosis.
- •Patient is on a weight loss program and is not in the maintenance phase or is taking weight loss medication.
- •Patient has had surgery within 30 days of starting the study or has planned major surgery during the study
Arms & Interventions
MK-0941
Intervention: MK-0941
MK-0941
Intervention: Metformin
Glimepiride
Intervention: Glimepiride
Glimepiride
Intervention: Metformin
Outcomes
Primary Outcomes
Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose
Time Frame: Baseline and Week 6
Weighted Mean Glucose (WMG) is a measure of the amount of glucose in the blood over a period of 24 hours. The WMG was derived from multiple glucose values collected during both fasting and post-meal periods. The "weighted" mean was used to avoid over-representation of post-meal glucose values.
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Time Frame: Baseline to Week 6
Hypoglycemic episodes are defined as either a fingerstick glucose measurement of ≤70 mg/dL \[3.9 mmol/L\] with or without symptoms or symptomatic hypoglycemia.