A 66-Week Extension to: A Phase IIb, Randomized, Placebo-Controlled, Dose-Range Finding, Clinical Trial to Study the Safety and Efficacy of MK-3102 in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control. (Original Study EudraCT # 2010-022193-13)
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 12.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2011-000656-42-FI
- Lead Sponsor
- MSD Finland Oy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 510
1. Complete the double-blind base study (with or without initiation of glycemic rescue medication with open-label metformin).
2. Have ³75% compliance with double-blind study medication during the base study double-blind treatment period.
3. Understand the extension study procedures and agree to participate in the extension by giving written informed consent.
4. Women of childbearing potential must continue to comply with the protocol-specified contraceptive methods as previously outlined in the base study.
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
1. Have any contraindication for the use of pioglitazone described in the package insert from the country of the investigational site.
2. Patient meets any of the base study criteria for discontinuation from the study drug.
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