A Phase IIb/III, 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 Insuli
- Conditions
- Treatment of Type 2 DiabetesMedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
- Registration Number
- EUCTR2008-002121-36-FR
- Lead Sponsor
- aboratoires Merck Sharp & Dohme-Chibret
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 550
Patient is 21 to 70 years old and currently on a stable dose of insulin for Type 2 Diabetes.
HbA1c at visit 4 ( randomization) HbA1c =7.5% and =11.0%
BMI > 20kg/m² and <43 kg/m² at visit 1 ( screening)
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
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, rimonabant) within 8 weeks of Visit 1;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
- Secondary Outcome Measures
Name Time Method