NCT00974740

DIATOR-Diabetes Intervention With Atorvastatin

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Profil Institut für Stoffwechselforschung GmbH · Industry
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	Atorvastatin	atorvastatin 40 mg (tablet for oral intake) once daily in the evening for 4 weeks, thereafter 80 mg for the remaining treatment period (total treatment period 18 months)
DRUG	atorvastatin matching placebo	atorvastatin matching placebo tablets once daily in the evening, corresponding to 40 mg atorvastatin for the first 4 weeks (run-in period), and corresponding to 80 mg atorvastatin thereafter (total treatment period 18 months)

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-01-01
• Completion: 2009-03-01
• First posted: 2009-09-10
• Last updated: 2017-06-19

Locations

12 sites across 1 country: Germany