DIATOR-Diabetes Intervention With Atorvastatin

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Profil Institut für Stoffwechselforschung GmbH
• Collaborator: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

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