Effect of Pioglitazone on Cardiovascular Outcome on Higashi-Saitama Trial in Patients With Type 2 Diabetes

Completed

• Conditions: Type 2 Diabetes; Hypertension; Dyslipidemia; Diabetic Nephropathy

• Registration Number: NCT00419484
• Lead Sponsor: Dokkyo Medical University

Brief Summary

We want to investigate the effects of pioglitazone on cardiovascular events in Japanese patients with type 2 diabetes.

Detailed Description

Primary composite endpoints:

Cardiovascular death Non-fatal myocardial infarction and angina Non-fatal stroke Renal failure (hemodialysis/doubling of serum creatinine)

Secondary endpoints:

urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout

Study Timeline

• Study Start: 2004-03
• Status Verified: 2007-01
• Study First Submitted: 2007-01-05
• Study First Submitted QC: 2007-01-05
• Last Update Submitted: 2007-01-05
• Study First Posted: 2007-01-08
• Last Update Posted: 2007-01-08
• Study Completion: 2008-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• type 2 diabetes HbA1c: more than 7% and less than 9%

Exclusion Criteria

• insulin treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Dokkyo Medical University, Koshigaya Hospital; 🇯🇵 Koshigaya, Saitama, Japan