Back to resultsDIATOR-Diabetes Intervention With Atorvastatin
Primary Purpose
Type 1 Diabetes
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Atorvastatin
atorvastatin matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes
Eligibility 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
Sites / Locations
- Diabetes-Zentrum Mergentheim
- Gemeinschaftskrankenhaus Havelhöhe
- Helios Klinikum Emil von Behring
- Praxis Dr. Friedhelm Schmitten
- DDZ Deutsches Diabetes Zentrum
- St. Josefs Krankenhaus
- St. Antonius Krankenhaus, Med. Klinik
- Praxisklinik Leipzig
- Praxis Dr. Gerhard Willms
- Praxis Dr. Heinz-Georg Ley
- Diabetologische Schwerpunktpraxis, Angiologie
- Praxis Dr. Werner Stürmer
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
atorvastatin matching placebo
atorvastatin
Arm Description
atorvastatin matching placebo
40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months
Outcomes
Primary Outcome Measures
C-peptide after a liquid mixed meal stimulation
Secondary Outcome Measures
HbA1c
insulin dose
adverse events
serum lipids
plasma CRP
Full Information
NCT ID
NCT00974740
First Posted
September 9, 2009
Last Updated
June 16, 2017
Sponsor
Profil Institut für Stoffwechselforschung GmbH
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00974740
Brief Title
DIATOR-Diabetes Intervention With Atorvastatin
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 Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Terminated
Why Stopped
for lack of recruitment
Study Start Date
March 2004 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Profil Institut für Stoffwechselforschung GmbH
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
atorvastatin matching placebo
Arm Type
Placebo Comparator
Arm Description
atorvastatin matching placebo
Arm Title
atorvastatin
Arm Type
Experimental
Arm Description
40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Sortis
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
atorvastatin matching placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
C-peptide after a liquid mixed meal stimulation
Time Frame
at randomization, after 12 months, and after 18 months of treatment
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
at randomization, after 6, 12, and 18 months of treatment
Title
insulin dose
Time Frame
at randomization, and after 3, 6, 12, and 18 months of treatment
Title
adverse events
Time Frame
at randomization, and after 3, 6, 12, and 18 months of treatment
Title
serum lipids
Time Frame
at randomization, and after 3, 6, 12, and 18 months of treatment
Title
plasma CRP
Time Frame
at randomization, and after 3, 12, and 18 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Martin, MD
Organizational Affiliation
DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes-Zentrum Mergentheim
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Gemeinschaftskrankenhaus Havelhöhe
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Name
Helios Klinikum Emil von Behring
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Praxis Dr. Friedhelm Schmitten
City
Bestwig-Ramsbeck
ZIP/Postal Code
59909
Country
Germany
Facility Name
DDZ Deutsches Diabetes Zentrum
City
Düsseldorf
ZIP/Postal Code
40221
Country
Germany
Facility Name
St. Josefs Krankenhaus
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
St. Antonius Krankenhaus, Med. Klinik
City
Köln
ZIP/Postal Code
50968
Country
Germany
Facility Name
Praxisklinik Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Praxis Dr. Gerhard Willms
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
Facility Name
Praxis Dr. Heinz-Georg Ley
City
Marl
ZIP/Postal Code
45770
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis, Angiologie
City
Münster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Praxis Dr. Werner Stürmer
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
23991111
Citation
Kolb H, Luckemeyer K, Heise T, Herder C, Schloot NC, Koenig W, Heinemann L, Martin S; DIATOR Study Group. The systemic immune network in recent onset type 1 diabetes: central role of interleukin-1 receptor antagonist (DIATOR Trial). PLoS One. 2013 Aug 26;8(8):e72440. doi: 10.1371/journal.pone.0072440. eCollection 2013.
Results Reference
derived
PubMed Identifier
22448235
Citation
Strom A, Kolb H, Martin S, Herder C, Simon MC, Koenig W, Heise T, Heinemann L, Roden M, Schloot NC; DIATOR Study Group. Improved preservation of residual beta cell function by atorvastatin in patients with recent onset type 1 diabetes and high CRP levels (DIATOR trial). PLoS One. 2012;7(3):e33108. doi: 10.1371/journal.pone.0033108. Epub 2012 Mar 20.
Results Reference
derived
PubMed Identifier
21412424
Citation
Martin S, Herder C, Schloot NC, Koenig W, Heise T, Heinemann L, Kolb H; DIATOR Study Group. Residual beta cell function in newly diagnosed type 1 diabetes after treatment with atorvastatin: the Randomized DIATOR Trial. PLoS One. 2011 Mar 11;6(3):e17554. doi: 10.1371/journal.pone.0017554.
Results Reference
derived
Learn more about this trial
DIATOR-Diabetes Intervention With Atorvastatin
We'll reach out to this number within 24 hrs