The Effect of Pioglitazone on Macrovascular Outcome (Death, Heart Attack, Acute Coronary Syndrome, Heart Bypass Surgery, Stroke, Leg Bypass Surgery or Amputation) in Patients With Type 2 Diabetes

Condition(s) targeted: Type 2 Diabetes

Intervention: Pioglitazone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Takeda Global Research & Development Center, Inc.

Official(s) and/or principal investigator(s):
John Dormandy, DSc, Study Chair, Affiliation: Department of Vascular Surgery, St. George's Hospital

The study is designed to see whether pioglitazone, in addition to its normal role of reducing blood sugar, can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes. Patients will receive pioglitazone or placebo in addition to their normal treatments for diabetes.

Official title: PROspective PioglitAzone Clinical Trial In MacroVascular Events (PROactive)A Macrovascular Outcome Study in Type 2 Diabetic Patients Comparing Pioglitazone With Placebo in Addition to Existing Therapy

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to death, non-fatal myocardial infarction, acute coronary syndrome, cardiac intervention (PCI/CABG), stroke, leg amputation, revascularisation in the leg. Minimum 30 months follow up

Secondary outcome: Adverse events

Detailed description: 5000 patients with type 2 diabetes who have an established history of macrovascular disease will receive pioglitazone or placebo in addition to their normal treatment for diabetes. Patients will be treated and followed for a minimum of 30 months. Patients who stop study medication will continue to be followed for the duration of the study. All macrovascular events (death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation) that occur during the study will be counted. Use of other medications and adverse events will be recorded throughout the study. The study will stop when the last patient enrolled has been in the study for a minimum of 30months and at least 760 events have occurred.

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- HbA1c > 6. 5%

- History of macrovascular disease

Exclusion Criteria:

- Type 1 diabetes

- Impaired liver function

- Heart failure (>/= NYHA II)

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Starting date: May 2001
Ending date: January 2005
Last updated: May 8, 2006