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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-000725-54-IT
Enrollment
Unknown
Registered
2006-12-27
Start date
2006-09-29
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

Type 2 diabetes and metabolic syndrome IDF definition MedDRA version: 9.1 Level: LLT Classification code 10022491 Term: Insulin resistant diabetes

Interventions

Trade Name: ACTOS*28CPR 15MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pioglitazone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutic

Sponsors

TAKEDA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the beneficial effect of combining pioglitazone and metformin on HDL-C at 24 weeks;Secondary Objective: To evaluate the effect of combining pioglitazone and metformin on the risk factors clustered in the IDF definition of MS, i.e. the changes in the aggregate of waist circumference, FPG, TG, HDL-C, BP. Moreover, individual metabolic parameters, insulin sensitivity and 946; cell function, inflammatory cytokines, adipokines, endothelial functionality, safety and tolerability will be measured;Primary end point(s): To evaluate the beneficial effect of combining pioglitazone and metformin on HDL-C at 24 weeks—

Countries

Italy

Outcome results

None listed

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