Double-blind, randomized, multicenter, parallel-group study to evaluate the effects of pioglitazone on metabolic syndrome in patients with type 2 diabetes treated with metformin - Pioglitazone Randomized Italian Study on MetAbolic syndrome PRISMA

• Conditions: Type 2 diabetes and metabolic syndrome IDF definition; MedDRA version: 9.1Level: LLTClassification code 10022491Term: Insulin resistant diabetes

• Registration Number: EUCTR2006-000725-54-IT
• Lead Sponsor: TAKEDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with type 2 diabetes, treated with metformin 2,000-3,000 mg/day for at least 3 months and with HbA1c levels between 6.5 and 7.5 , central obesity defined as waist circumference 94 cm for men and 80 cm for women , and reduced HDL-C 40 mg/dL in males and 50 mg/dL in females irrespective of treatment with statins, will be enrolled in the study.
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

diagnosis of type 1 diabetes mellitus; treatment with other oral antidiabetic drugs than metformin or with insulin in the 3 months preceding study entry; treatment with fibrates; pregnant or lactating female heart failure NYHA I-IV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified