Effects of Pioglitazone in Combination with Glimepiride in Comparison to Glimepiride Monotherapy on Metabolic Control in Patients with Type 2 Diabetes mellitus
- Conditions
- Patients with Type 2 Diabetes mellitus and HbA1c > 6,5%, but < 8,5% and/ or fasting plasma glucose > 7 mmol/l will be eligible for the studyMedDRA version: 8.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate control
- Registration Number
- EUCTR2006-002271-41-DE
- Lead Sponsor
- Takeda Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patients with type 2 diabetes mellitus, HbA1c > 6,5%, but < 8,5% and/ or fasting plasma glucose > 7 mmol/l, male or female, age 30-75 years, inefficiently treated with Glimepiride monotherapy (1-3 mg) 3 months before entering the study, patients having signed informed consent
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
Type 1 diabetes mellitus, hypersensitivity to the study drugs, progressive fatal disease, more than one unexplained episode of severe hypoglycaemia within 6 months prior to study entry, history of significant cardiovascular (NYHA I-IV), respiratory, gastrointestinal, hepatic, renal, neurological, psychatric and/ or hematological disease, lack of compliance, pretreatment with thiazolidinedions within the last 12 months, pretreatment with other anti-diabetic drugs than Glimepiride within the last 3 months
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