DIATOR-Diabetes Intervention With Atorvastatin

This study has been terminated.
(for lack of recruitment)
Sponsor:
Collaborator:
Pfizer
Information provided by:
Profil Institut für Stoffwechselforschung GmbH
ClinicalTrials.gov Identifier:
NCT00974740
First received: September 9, 2009
Last updated: September 10, 2009
Last verified: September 2009

September 9, 2009
September 10, 2009
March 2004
January 2008   (final data collection date for primary outcome measure)
C-peptide after a liquid mixed meal stimulation [ Time Frame: at randomization, after 12 months, and after 18 months of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974740 on ClinicalTrials.gov Archive Site
  • HbA1c [ Time Frame: at randomization, after 6, 12, and 18 months of treatment ] [ Designated as safety issue: No ]
  • insulin dose [ Time Frame: at randomization, and after 3, 6, 12, and 18 months of treatment ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: at randomization, and after 3, 6, 12, and 18 months of treatment ] [ Designated as safety issue: Yes ]
  • serum lipids [ Time Frame: at randomization, and after 3, 6, 12, and 18 months of treatment ] [ Designated as safety issue: No ]
  • plasma CRP [ Time Frame: at randomization, and after 3, 12, and 18 months of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 1 Diabetes
  • 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)
    Other Name: Sortis
  • 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)
  • Placebo Comparator: atorvastatin matching placebo
    atorvastatin matching placebo
    Intervention: Drug: atorvastatin matching placebo
  • Experimental: atorvastatin
    40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months
    Intervention: Drug: Atorvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
63
March 2009
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00974740
33/0136-Diator
No
Tim Heise, MD, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
Profil Institut für Stoffwechselforschung GmbH
Pfizer
Principal Investigator: Stefan Martin, MD DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany
Profil Institut für Stoffwechselforschung GmbH
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP