A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)
Phase 2
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00792935
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 143
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MK-0941 MK-0941 - MK-0941 Metformin - Glimepiride Glimepiride - Glimepiride Metformin -
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 6 in 24-hour Weighted Mean Glucose 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) 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.
- Secondary Outcome Measures
Name Time Method