Residual beta cell function in newly diagnosed type 1 diabetes after treatment with atorvastatin: the Randomized DIATOR Trial

PLoS One. 2011 Mar 11;6(3):e17554. doi: 10.1371/journal.pone.0017554.

Abstract

Background: Recent evidence suggests that the lipid-lowering agent atorvastatin is also a potent immunomodulator. The aim of this study was to investigate the possible effect of atorvastatin on the decline of residual beta cell function in recent-onset type 1 diabetes.

Methods and findings: The randomised placebo-controlled Diabetes and Atorvastatin (DIATOR) Trial included 89 patients with newly diagnosed type 1 diabetes and islet autoantibodies (mean age 30 years, 40% females), in 12 centres in Germany. Patients received placebo or 80 mg/d atorvastatin for 18 months. As primary outcome stimulated serum C-peptide levels were determined 90 min after a standardized liquid mixed meal. An intent-to-treat analysis was performed. Fasting and stimulated C-peptide levels were not significantly different between groups at 18 months. However, median fasting serum C-peptide levels dropped from baseline to 12 and 18 months in the placebo group (from 0. 34 to 0.23 and 0.20 nmol/l, p<0.001) versus a nonsignificant decline in the atorvastatin group (from 0.34 to 0.27 and 0.30 nmol/l, ns). Median stimulated C-peptide concentrations declined between baseline and 12 months (placebo from 0.89 to 0.71 nmol/l, atorvastatin from 0.88 to 0.73 nmol/l, p<0.01 each) followed by a major loss by month 18 in the placebo group (to 0.48 nmol/l, p = 0.047) but not in the atorvastatin group (to 0.71 nmol/l, ns). Median levels of total cholesterol and C-reactive protein decreased in the atorvastatin group only (p<0.001 and p = 0.04). Metabolic control was similar between groups.

Conclusions: Atorvastatin treatment did not significantly preserve beta cell function although there may have been a slower decline of beta-cell function which merits further study.

Trial registration: ClinicalTrials.gov NCT00974740.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Atorvastatin
  • C-Peptide / metabolism
  • Diabetes Mellitus, Type 1 / diagnosis
  • Diabetes Mellitus, Type 1 / drug therapy*
  • Diabetes Mellitus, Type 1 / physiopathology*
  • Female
  • Glycated Hemoglobin A / metabolism
  • Heptanoic Acids / adverse effects
  • Heptanoic Acids / pharmacology
  • Heptanoic Acids / therapeutic use*
  • Humans
  • Insulin-Secreting Cells / drug effects
  • Insulin-Secreting Cells / pathology*
  • Lipids / blood
  • Male
  • Pyrroles / adverse effects
  • Pyrroles / pharmacology
  • Pyrroles / therapeutic use*
  • Treatment Outcome

Substances

  • C-Peptide
  • Glycated Hemoglobin A
  • Heptanoic Acids
  • Lipids
  • Pyrroles
  • Atorvastatin

Associated data

  • ClinicalTrials.gov/NCT00974740