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DIATOR-Diabetes Intervention With Atorvastatin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974740
Recruitment Status : Terminated (for lack of recruitment)
First Posted : September 10, 2009
Last Update Posted : June 19, 2017
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Atorvastatin Drug: atorvastatin matching placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2004
Actual Primary Completion Date : January 2008
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Placebo Comparator: atorvastatin matching placebo
atorvastatin matching placebo
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)

Experimental: atorvastatin
40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months
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

Primary Outcome Measures :
  1. C-peptide after a liquid mixed meal stimulation [ Time Frame: at randomization, after 12 months, and after 18 months of treatment ]

Secondary Outcome Measures :
  1. HbA1c [ Time Frame: at randomization, after 6, 12, and 18 months of treatment ]
  2. insulin dose [ Time Frame: at randomization, and after 3, 6, 12, and 18 months of treatment ]
  3. adverse events [ Time Frame: at randomization, and after 3, 6, 12, and 18 months of treatment ]
  4. serum lipids [ Time Frame: at randomization, and after 3, 6, 12, and 18 months of treatment ]
  5. plasma CRP [ Time Frame: at randomization, and after 3, 12, and 18 months of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974740

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Diabetes-Zentrum Mergentheim
Bad Mergentheim, Germany, 97980
Gemeinschaftskrankenhaus Havelhöhe
Berlin, Germany, 14089
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
Praxis Dr. Friedhelm Schmitten
Bestwig-Ramsbeck, Germany, 59909
DDZ Deutsches Diabetes Zentrum
Düsseldorf, Germany, 40221
St. Josefs Krankenhaus
Heidelberg, Germany, 69115
St. Antonius Krankenhaus, Med. Klinik
Köln, Germany, 50968
Praxisklinik Leipzig
Leipzig, Germany, 04103
Praxis Dr. Gerhard Willms
Leverkusen, Germany, 51373
Praxis Dr. Heinz-Georg Ley
Marl, Germany, 45770
Diabetologische Schwerpunktpraxis, Angiologie
Münster, Germany, 48145
Praxis Dr. Werner Stürmer
Würzburg, Germany, 97070
Sponsors and Collaborators
Profil Institut für Stoffwechselforschung GmbH
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Principal Investigator: Stefan Martin, MD DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Profil Institut für Stoffwechselforschung GmbH Identifier: NCT00974740    
Other Study ID Numbers: 33/0136-Diator
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
type 1 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors