Role of Pioglitazone in Preventing Diabetes

Phase 1

Completed

• Conditions: Diabetes

• Registration Number: NCT00276497
• Lead Sponsor: M.V. Hospital for Diabetes

Brief Summary

A three year prospective, double blinded, placebo controlled, randomized clinical trial in impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing the conversion to Diabetes.

Detailed Description

A randomized controlled study was designed to find out whether pioglitazone will prevent the conversion to diabetes in subjects who are non obese and with impaired glucose tolerance.

It is a double blind prospective study for 3 years. The study was started in October 2003 and randomization was completed in May 2005. A total of 6643 subjects were screened and 406 were randomized either to pioglitazone or placebo(investigator blinded-groups assigned A and B). At randomisation subjects were given standard advice on diet,exercise and benefits of life style modifications.

Subjects both male and female, aged between 35 and 55 years, with no known history of diabetes, willing and available for a 3 year study alone were screened. Pregnant women, subjects with major illness such as cancer, hepatic or cardiac diseases and on transferable jobs were excluded from the study. The initial dose of tablet was 15mg o.d. which was titrated after a month to 30 mg o.d. in subjects who did not show any adverse events.

The subjects will be undergoing annual reviews with a repeat OGTT, for 3 years. An interim review at every six months is also being done. Proforma containing details of anthropometry, occupation, physical activity, dietary habits, details of medications, regularity of treatment will be done at each interview.

The main expected outcomes of the study will be a reduction in conversion of IGT to diabetes and benefits of the drug on anthropometric variables and biochemical parameters.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2006-01-12
• Study First Submitted QC: 2006-01-12
• Study First Posted: 2006-01-13
• Study Completion: 2008-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-03
• Last Update Posted: 2009-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Both male and female
• Age 35 - 55 years
• No known history of diabetes
• Willing and available for a 3 years study

Exclusion Criteria

• Pregnant women
• Subjects with major illness such as cancer, hepatic or cardiac diseases
• Transferable jobs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in conversion of IGT to diabetes

Secondary Outcome Measures

Name	Time	Method
benefits of the drug on anthropometric variables and biochemical parameters