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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
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)
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)
Diabetes-Zentrum Mergentheim
Bad Mergentheim, Germany
Gemeinschaftskrankenhaus Havelhöhe
Berlin, Germany
Helios Klinikum Emil von Behring
Berlin, Germany
C-peptide after a liquid mixed meal stimulation
Time frame: at randomization, after 12 months, and after 18 months of treatment
HbA1c
Time frame: at randomization, after 6, 12, and 18 months of treatment
insulin dose
Time frame: at randomization, and after 3, 6, 12, and 18 months of treatment
adverse events
Time frame: at randomization, and after 3, 6, 12, and 18 months of treatment
serum lipids
Time frame: at randomization, and after 3, 6, 12, and 18 months of treatment
plasma CRP
Time frame: at randomization, and after 3, 12, and 18 months of treatment
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Praxis Dr. Friedhelm Schmitten
Bestwig-Ramsbeck, Germany
St. Antonius Krankenhaus, Med. Klinik
Cologne, Germany
DDZ Deutsches Diabetes Zentrum
Düsseldorf, Germany
St. Josefs Krankenhaus
Heidelberg, Germany
Praxisklinik Leipzig
Leipzig, Germany
Praxis Dr. Gerhard Willms
Leverkusen, Germany
Praxis Dr. Heinz-Georg Ley
Marl, Germany
...and 2 more locations