A double-blind, randomized, multicenter study evaluating the effects of pioglitazone in fasting Muslim subjects during Ramadan

Senthil Vasan, Nihal Thomas, Bharani, Mohammed Ameen, Sunil Abraham, Victoria Job, Beulah John, Rajani Karol, M. Kavitha, Kurian Thomas, M. Seshadri

Research output: Contribution to journalArticlepeer-review

27 Scopus citations

Abstract

Aim: Hypoglycemia in fasting subjects with diabetes during Ramadan is a problem that demands attention. We aimed to assess the efficacy and cost-effectiveness of pioglitazone on subjects fasting during the Ramadan period and to determine its role in improving the glycemic control and reducing hypoglycemic episodes when used as an adjunctive form of therapy for subjects with type 2 diabetes mellitus. Methodology: This multicenter, double-blind randomized controlled trial included 86 fasting Muslim subjects with type 2 diabetes mellitus. The study was initiated 74 days prior to Ramadan to optimize glycemic control. The subjects were randomized to 30 mg of pioglitazone once daily and placebo in addition to the existing oral hypoglycemic agents (OHAs) and the doses of other OHAs were titrated according to their glycemic status at each visit. Primary outcomes included were glycemic control, as assessed by serum fructosamine, and number of hypoglycemic episodes per week during Ramadan. Secondary outcome evaluated the cost-effectiveness in using pioglitazone as an adjuvant form of therapy to conventional OHAs. Results: Pioglitazone was tolerated well by subjects in this study. Glycemic control was better during early Ramadan (Fructosamine: 320.80 versus 360.94 μM/l, P =0.02), mid-Ramadan (fructosamine: 315.92 versus 374.79 μM/l, P =0.003), and 2 weeks post-Ramadan, (which reflects the glycemic control in the last week of Ramadan) (320.45 versus 375.12 μM/l, P =0.01) in patients in the pioglitazone arm versus those on placebo. There was no significant difference in the number of hypoglycemic events between the two groups ( P =0.21). The common adverse effects in the pioglitazone arm were a mean weight gain of 3.02 kg ( P =0.001) and ankle edema in 16 subjects ( P =0.0002). Direct cost per month per subject in the pioglitazone group was INR 780.62 (US $17.36) vs INR 1232.50 (US $27.41) in the placebo group ( P =0.02). Conclusion: Pioglitazone is safe and efficacious in lowering blood glucose in fasting subjects during Ramadan in combination with other OHAs. There is no reduction in the number of hypoglycemic events when compared with conventional therapy without pioglitazone. There is a significant cost benefit when pioglitazone is added to other OHAs in this study.

Original languageEnglish
Pages (from-to)70-76
Number of pages7
JournalInternational Journal of Diabetes in Developing Countries
Volume26
Issue number2
DOIs
StatePublished - 1 Apr 2006
Externally publishedYes

Keywords

  • Hypoglycemia
  • Muslims
  • Pioglitazone
  • Ramadan

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