.A.
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 14.0Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2011-000656-42-LT
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 663
1. Complete the double-blind base study (with or without initiation of glycemic rescue medication with open-label metformin).
2. Have = 75% 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 332
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 331
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 Main Objective: To assess the safety and tolerability of MK-3102 treatment. ;Secondary Objective: To assess the changes from baseline in A1C with MK-3102 treatment.<br>To assess the changes from baseline in 2-hr Post Meal Glucose (PMG) with MK-3102 treatment.<br>To assess the changes from baseline in fasting plasma glucose (FPG) with MK-3102 treatment.<br>;Primary end point(s): Safety (collection of adverse experiences, physical exam and vital signs, laboratory safety studies and ECG) and tolerability of MK-3102 treatment;Timepoint(s) of evaluation of this end point: 78 weeks after randomization in the main Merck Sharp & Dohme Corp. clinical trial MK-3102-006
- Secondary Outcome Measures
Name Time Method Secondary end point(s): is secondary objectives ;Timepoint(s) of evaluation of this end point: 78 weeks after randomization in the main Merck Sharp & Dohme Corp. clinical trial MK-3102-006 <br>