Status:
TERMINATED
DIATOR-Diabetes Intervention With Atorvastatin
Lead Sponsor:
Profil Institut für Stoffwechselforschung GmbH
Collaborating Sponsors:
Pfizer
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-39 years
Phase:
PHASE1
Brief 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 stu...
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 n...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00974740
Start Date
March 1 2004
End Date
March 1 2009
Last Update
June 19 2017
Active Locations (12)
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1
Diabetes-Zentrum Mergentheim
Bad Mergentheim, Germany, 97980
2
Gemeinschaftskrankenhaus Havelhöhe
Berlin, Germany, 14089
3
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
4
Praxis Dr. Friedhelm Schmitten
Bestwig-Ramsbeck, Germany, 59909