A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK-0941 in Patients with Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin - Dose-Range Finding Study of MK-0941 in Patients with Type 2 Diabetes on Insuli
Phase 1
- Conditions
- Type II diabetes mellitusMedDRA version: 9.1Level: LLTClassification code 10012601Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2008-002121-36-HU
- Lead Sponsor
- Merck & Co. Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 950
Inclusion Criteria
Patient is 21 to 70 years old and currently on a stable dose of insulin for Type 2 Diabetes
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Patient has any history of Type 1 Diabetes; patient is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine) within 8 weeks of Visit 1/screening visit; patient has undergone surgery within 30 days prior to Visit 1 or has planned major surgery.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: After 14 weeks, to assess the effect of treatment with MK-0941 compared with placebo on HbA1c reduction when added to basal insulin.;Secondary Objective: After 14 weeks, to assess the of treatment with MK-0941 compared with placebo on on 2-hour post-prandial glucose when added to basal insulin.;Primary end point(s): HbA1c
- Secondary Outcome Measures
Name Time Method