DIATOR-Diabetes Intervention With Atorvastatin

Profil Institut für Stoffwechselforschung

Status and phase

Terminated

Phase 1

Conditions

Type 1 Diabetes

Treatments

Drug: atorvastatin matching placebo

Drug: Atorvastatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00974740

33/0136-Diator

Details and patient eligibility

About

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.

Full 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

Enrollment

63 patients

Sex

All

Ages

18 to 39 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ADA criteria at least two weeks but not later than 3 months after start of insulin treatment
Age 18 to 39 years, inclusive
Male patient or female patient using adequate contraceptive methods
Tested positive for at least one of the three islet autoantibodies GAD65, IA2 or ICA

Exclusion criteria

History of a malignancy
Presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated more than ten percent above the upper limit of normal, elevation of AST or ALT more than 3 times the upper limit of normal
Any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator
Current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin
Pregnant or nursing women or women intending to become pregnant
Known or suspected allergy to atorvastatin or any component of thr trial product
Known myopathy, myalgia or myositis with a serum-CPK above 3 times the upper limit of normal
Patients who had a severe blood loss (>= 400 mL, e.g. blood donation) within 2 months prior to visit 2
Any significant laboratory abnormality
A serum LDL-cholesterol above 150 mg/dL at time of screening
Unwillingness to comply with study procedures