Role of Pioglitazone in Preventing Diabetes

Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276497
• Other study ID #: IDPP2
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2006
• Last updated: April 3, 2009
• Start date: October 2003
• Est. completion date: May 2008

Study information

• Verified date: April 2009
• Source: M.V. Hospital for Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 55 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Pioglitazone

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
M.V. Hospital for Diabetes	India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

References & Publications (1)

Ramachandran A, Snehalatha C, Mary S, Selvam S, Kumar CK, Seeli AC, Shetty AS. Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in conversion of IGT to diabetes
Secondary	benefits of the drug on anthropometric variables and biochemical parameters