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
  Purpose

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 Intervention Phase
Type 1 Diabetes
Drug: Atorvastatin
Drug: atorvastatin matching placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Profil Institut für Stoffwechselforschung GmbH:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 63
Study Start Date: March 2004
Study Completion Date: March 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974740

Locations
Germany
Diabetes-Zentrum Mergentheim
Bad Mergentheim, Germany, 97980
Helios Klinikum Emil von Behring
Berlin, Germany, 14165
Gemeinschaftskrankenhaus Havelhöhe
Berlin, Germany, 14089
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
Pfizer
Investigators
Principal Investigator: Stefan Martin, MD DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany
  More Information

No publications provided by Profil Institut für Stoffwechselforschung GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tim Heise, MD, Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany
ClinicalTrials.gov Identifier: NCT00974740     History of Changes
Other Study ID Numbers: 33/0136-Diator
Study First Received: September 9, 2009
Last Updated: September 10, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Profil Institut für Stoffwechselforschung GmbH:
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014