A pilot randomized controlled trial of renal protection with pioglitazone in diabetic nephropathy

Rajiv Agarwal, Chandan Saha, Meher Battiwala, Nina Vasavada, Timothy Curley, Shawn D. Chase, Nadine Sachs, Merfake H. Semret

Research output: Contribution to journalArticle

55 Scopus citations


Background. Diabetic nephropathy progresses relentlessly to end-stage renal disease (ESRD). Animal experiments have found that peroxisome proliferator activated receptor-γ (PPAR-γ)-based therapy can have a glucose independent effect on renal protection. We hypothesized that PPAR-y-based antidiabetic therapy would result in greater reduction in proteinuria compared to sulfonylurea-based therapy. Methods. In 44 patients with overt diabetic nephropathy, an open-label, blinded end point trial was conducted in which subjects were randomized to either pioglitazone or glipizide to achieve similar glucose control. Proteinuria was assessed by two collections of 24-hour urine samples each month for 4 months. Results. The glipizide group had an adjusted mean increase in proteinuria of 6.1% (95% CI -11.7%, 23.8%), whereas the pi-oglitazone group had a reduction of 7.2% (95% CI -24.9%, 10.6%). The adjusted reduction with pioglitazone of 13.2% (95% CI -38.4%, 11.9%) was not statistically significant (P = 0.294). Baseline proteinuria, diastolic ambulatory blood pressure, and serum albumin concentration were independent predictors of reduction in proteinuria. The frequency and patterns of adverse events were similar in the two groups. Conclusion. In patients with advanced diabetic nephropathy, we found no reduction in proteinuria over 4 months. These data are useful to design larger studies with longer duration of follow-up to demonstrate renal protection of PPAR-γ agonists.

Original languageEnglish (US)
Pages (from-to)285-292
Number of pages8
JournalKidney international
Issue number1
StatePublished - Jul 1 2005
Externally publishedYes


  • Ambulatory blood pressure monitoring
  • Diabetic nephropathy
  • Glomerular filtration rate
  • Pioglitazone
  • Proteinuria

ASJC Scopus subject areas

  • Nephrology

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