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Effects of Pioglitazone in Combination with Glimepiride in Comparison to Glimepiride Monotherapy on Metabolic Control in Patients with Type 2 Diabetes mellitus

Effects of Pioglitazone in Combination with Glimepiride in Comparison to Glimepiride Monotherapy on Metabolic Control in Patients with Type 2 Diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-002271-41-DE
Enrollment
Unknown
Registered
2006-08-10
Start date
2006-10-25
Completion date
Unknown
Last updated
2012-03-19

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 and HbA1c > 6,5%, but 7 mmol/l will be eligible for the study MedDRA version: 8.1 Level: LLT Classification code 10063624 Term: Type II diabetes mellitus inadequate control

Interventions

Trade Name: Actos 45 mg Pharmaceutical Form: Tablet INN or Proposed INN: Pioglitazone HCl Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- Pharmaceutical form of

Sponsors

Takeda Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus, HbA1c > 6,5%, but 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the influence of Pioglitazone in combination with Glimepiride in comparison to Glimepiride monotherapy on the change in beta-cell function as assessed by the HOMA-B score;Secondary Objective: To evaluate the changes of HbA1c, HOMA-S and several other parameters as glucose, insulin, intact proinsulin, C-Peptide, adiponectin, lipids and hsCRP;Primary end point(s): The primary efficacy variable will be the change in HOMA-B score from baseline (visit 2) after 24 weeks of treatment.—

Countries

Germany

Outcome results

None listed

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