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Trial record 1 of 1 for:    NCT00974740
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DIATOR-Diabetes Intervention With Atorvastatin

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ClinicalTrials.gov Identifier: NCT00974740
Recruitment Status : Terminated (for lack of recruitment)
First Posted : September 10, 2009
Last Update Posted : June 19, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

Tracking Information
First Submitted Date  ICMJE September 9, 2009
First Posted Date  ICMJE September 10, 2009
Last Update Posted Date June 19, 2017
Study Start Date  ICMJE March 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
C-peptide after a liquid mixed meal stimulation [ Time Frame: at randomization, after 12 months, and after 18 months of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DIATOR-Diabetes Intervention With Atorvastatin
Official Title  ICMJE 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
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 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.
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 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 9, 2009)
63
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00974740
Other Study ID Numbers  ICMJE 33/0136-Diator
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Profil Institut für Stoffwechselforschung GmbH
Study Sponsor  ICMJE Profil Institut für Stoffwechselforschung GmbH
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Stefan Martin, MD DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany
PRS Account Profil Institut für Stoffwechselforschung GmbH
Verification Date June 2017

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