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Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2)

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Ramachandran, A., Snehalatha, C., Mary, S., Selvam, S., Kumar, C. K. S., Seeli, A. C., Shetty, A. S.·2009·Diabetologia

DOI 10.1007/s00125-009-1315-x

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Abstract

Aims/hypothesis The objective of this prevention programme was to study whether combining pioglitazone with lifestyle modification would enhance the efficacy of lifestyle modification in preventing type 2 diabetes in Asian Indians with impaired glucose tolerance.Methods In a community-based, placebo-controlled 3 year prospective study, 407 participants with impaired glucose tolerance (mean age 45.3 +/- 6.2 years, mean BMI 25.9 +/- 3.3 kg/m(2)) were sequentially grouped to receive either: lifestyle modification plus pioglitazone, 30 mg (n = 204) or lifestyle modification plus placebo (n = 203). The participants and investigators were blinded to the assignment. The primary outcome was development of diabetes.Results At baseline, both groups had similar demographic, anthropometric and biochemical characteristics. At year 3, the response rate was 90.2%. The cumulative incidence of diabetes was 29.8% with pioglitazone and 31.6% with placebo (unadjusted HR 1.084 [95% CI 0.753-1.560], p = 0.665). Normoglycaemia was achieved in 40.9% and 32.3% of participants receiving pioglitazone and placebo, respectively (p = 0.109). In pioglitazone group, two deaths and two non-fatal hospitalisations occurred due to cardiac problems; in the placebo group there were two occurrences of cardiac disease.Conclusions/interpretation Despite good adherence to lifestyle modification and drug therapy, no additional effect of pioglitazone was seen above that achieved with placebo. The effectiveness of the intervention in both groups was comparable with that of lifestyle modification alone, as reported from the Indian Diabetes Prevention Programme-1. The results are at variance with studies that showed significant relative risk reduction in conversion to diabetes with pioglitazone in Americans with IGT. An ethnicity-related difference in the action of pioglitazone in non-diabetic participants may be one explanation.Trial registration ClinicalTrials.gov NCT00276497 FUNDING: This study was funded by the India Diabetes Research Foundation.

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Authors: Ramachandran, A., Snehalatha, C., Mary, S., Selvam, S., Kumar, C. K. S., Seeli, A. C., & Shetty, A. S.
Affiliations: India Diabetes Research Foundation (IN)
Corresponding author: Ramachandran, A.
ORCID: Ramachandran, A.
Venue: Diabetologia
Publisher: Springer Science and Business Media LLC
Published: 2009-03-10
Volume: 52
Issue: 6
Pages: 1019-1026
ISSN: 0012-186X (ISSN-L)
1432-0428
DOI: 10.1007/s00125-009-1315-x
OpenAlex: W1968039145
Cited by: 105
References: 24
Citations by year: 2026: 3 · 2025: 4 · 2024: 13 · 2023: 6 · 2022: 5 · 2021: 5 · 2020: 9 · 2019: 2 · 2018: 11 · 2017: 3 · 2016: 7 · 2015: 6 · 2014: 6 · 2013: 3 · 2012: 7
FWCI: 5.09
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.springer.com/tdm (tdm)
Locations: Diabetologia (publishedVersion)
PubMed (publishedVersion)
Funders: Emory University
India Diabetes Research Foundation
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords: pioglitazone, impaired glucose tolerance, type 2 diabetes prevention, lifestyle modification, Asian Indians, ethnic differences in drug response, PPARγ agonists, adverse cardiac events
MeSH terms: Pioglitazone, Adult, Combined Modality Therapy, Diabetes Mellitus, Type 2, Female, Humans, Hypoglycemic Agents, Life Style, Male, Middle Aged, Models, Theoretical, Prospective Studies, Glucose Intolerance, Asian People, Thiazolidinediones

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Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2)

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