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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004455-37-DE

Enrollment

260

Registered

2007-04-23

Start date

2007-03-05

Completion date

Unknown

Last updated

2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 8.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control

Interventions

Trade Name: Competact 15 mg/ 850 mg Pharmaceutical Form: Tablet INN or Proposed INN: Pioglitazon/ Metformin HCl Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15/

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus, HbA1c > 6.5% and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026