DIATOR-Diabetes Intervention With Atorvastatin

Type 1 Diabetes Clinical Trial

Official title: DIATOR - Diabetes Intervention With Atorvastatin. A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Investigate the Effect of Atorvastatin on Residual Beta-cell Function and Glycemic Control in Patients With Newly Diagnosed Type 1 Diabetes Mellitus

Status Terminated

Clinical Trial Summary

Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.

Clinical Trial Description

The objectives of this study were as follows:

• To assess the effect of atorvastatin on pancreatic beta-cell function as measured by C-peptide after a liquid mixed meal stimulation in patients with newly diagnosed type 1 diabetes,

• To assess the effect on metabolic control as measured by HbA1c and insulin requirements,

• To assess safety and tolerability of atorvastatin in subjects with newly diagnosed type 1 diabetes,

• To assess the effect on risk factors of diabetic complications as indicated by changes in lipids and CRP, and

• To assess the effect on systemic immune abnormalities as measured by effects on beta-cell autoantibodies, blood cytokines and chemokines on protein and transcriptional level.

Study duration: 18 months ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT00974740
• Study type: Interventional
• Source: Profil Institut für Stoffwechselforschung GmbH
• Status: Terminated
• Phase: Phase 1
• Start date: March 2004
• Completion date: March 2009