DIATOR-Diabetes Intervention With Atorvastatin

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00974740
• Other study ID #: 33/0136-Diator
• Status: Terminated
• Phase: Phase 1
• First received: September 9, 2009
• Last updated: June 16, 2017
• Start date: March 2004
• Est. completion date: March 2009

Study information

• Verified date: June 2017
• Source: Profil Institut für Stoffwechselforschung GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: March 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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)
• 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)

Locations

Country	Name	City	State
Germany	Diabetes-Zentrum Mergentheim	Bad Mergentheim
Germany	Gemeinschaftskrankenhaus Havelhöhe	Berlin
Germany	Helios Klinikum Emil von Behring	Berlin
Germany	Praxis Dr. Friedhelm Schmitten	Bestwig-Ramsbeck
Germany	DDZ Deutsches Diabetes Zentrum	Düsseldorf
Germany	St. Josefs Krankenhaus	Heidelberg
Germany	St. Antonius Krankenhaus, Med. Klinik	Köln
Germany	Praxisklinik Leipzig	Leipzig
Germany	Praxis Dr. Gerhard Willms	Leverkusen
Germany	Praxis Dr. Heinz-Georg Ley	Marl
Germany	Diabetologische Schwerpunktpraxis, Angiologie	Münster
Germany	Praxis Dr. Werner Stürmer	Würzburg

Sponsors (2)

Lead Sponsor	Collaborator
Profil Institut für Stoffwechselforschung GmbH	Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide after a liquid mixed meal stimulation		at randomization, after 12 months, and after 18 months of treatment
Secondary	HbA1c		at randomization, after 6, 12, and 18 months of treatment
Secondary	insulin dose		at randomization, and after 3, 6, 12, and 18 months of treatment
Secondary	adverse events		at randomization, and after 3, 6, 12, and 18 months of treatment
Secondary	serum lipids		at randomization, and after 3, 6, 12, and 18 months of treatment
Secondary	plasma CRP		at randomization, and after 3, 12, and 18 months of treatment