DIATOR-Diabetes Intervention With Atorvastatin
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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. |
| ClinicalTrials.gov Identifier: NCT00974740 |
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Recruitment Status :
Terminated
(for lack of recruitment)
First Posted : September 10, 2009
Last Update Posted : June 19, 2017
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Sponsor:
Profil Institut für Stoffwechselforschung GmbH
Collaborator:
Pfizer
Information provided by (Responsible Party):
Profil Institut für Stoffwechselforschung GmbH
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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 |
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 : | 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 Genetics related topics:
Type 1 diabetes
MedlinePlus related topics:
Diabetes Type 1
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: atorvastatin matching placebo
atorvastatin matching placebo
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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) |
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Experimental: atorvastatin
40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months
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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 :
- C-peptide after a liquid mixed meal stimulation [ Time Frame: at randomization, after 12 months, and after 18 months of treatment ]
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years to 39 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
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 ClinicalTrials.gov identifier (NCT number): NCT00974740
Locations
| Germany | |
| 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
Pfizer
Investigators
| Principal Investigator: | Stefan Martin, MD | DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Profil Institut für Stoffwechselforschung GmbH |
| ClinicalTrials.gov 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:
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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 Atorvastatin |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |