Effects of a Pioglitazone/ Metformin Fixed Combination in Comparison to Metformin in Combination with Glimepiride on Diabetic Dyslipidemia

Conditions: Patients with Type 2 Diabetes mellitus (HbA1c > 6.5% and >/ = 9%) and diabetic dylipidemia inefficiently treated with Metformin monotherapy (maximal individually tolerated dose) will be eligible for this trial.
MedDRA version: 8.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate control

Registration Number: EUCTR2006-004455-37-DE

Lead Sponsor: Takeda Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 260

Inclusion Criteria

Patients with type 2 diabetes mellitus, HbA1c > 6.5% and 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

Type 1 diabetes mellitus, progressive fatal disease, history of significant cardiovascular (NYHA I-IV), respiratory, gastrointestinal, hepatic, renal, neurological, psychatric and/ or hematological disease, history of macular oedema, change in dosage of statin treatment, change in dosage of anticoagulant treatment, start of statin and/ or anticoagulant treatment during study participation, sexually active women not consistenly or correctly practicing birth control, lack of compliance

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the influence of a Pioglitazone/ Metformin fix combination in comparison to a Glimepiride plus Metformin combinational therapy on the mean increase of the primary efficacy parameter HDL cholesterol;Secondary Objective: To evaluate the changes of the lipid profile, glycaemic control, inflammatory parameters and thrombocyte function;Primary end point(s): The primary efficacy variable will be the mean increase of HDL cholesterol from baseline (visit 2) to end of treatment (visit5) after 24 weeks

Secondary Outcome Measures