NCT00974740

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_1

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
Last Updated

June 19, 2017

Status Verified

June 1, 2017

Enrollment Period

3.8 years

First QC Date

September 9, 2009

Last Update Submit

June 16, 2017

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • C-peptide after a liquid mixed meal stimulation

    at randomization, after 12 months, and after 18 months of treatment

Secondary Outcomes (5)

  • HbA1c

    at randomization, after 6, 12, and 18 months of treatment

  • insulin dose

    at randomization, and after 3, 6, 12, and 18 months of treatment

  • adverse events

    at randomization, and after 3, 6, 12, and 18 months of treatment

  • serum lipids

    at randomization, and after 3, 6, 12, and 18 months of treatment

  • plasma CRP

    at randomization, and after 3, 12, and 18 months of treatment

Study Arms (2)

atorvastatin matching placebo

PLACEBO COMPARATOR

atorvastatin matching placebo

Drug: atorvastatin matching placebo

atorvastatin

EXPERIMENTAL

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

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

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)

Also known as: Sortis
atorvastatin
atorvastatin matching placeboDRUG

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)

atorvastatin matching placebo

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Diabetes-Zentrum Mergentheim

Bad Mergentheim, 97980, Germany

Location

Gemeinschaftskrankenhaus Havelhöhe

Berlin, 14089, Germany

Location

Helios Klinikum Emil von Behring

Berlin, 14165, Germany

Location

Praxis Dr. Friedhelm Schmitten

Bestwig-Ramsbeck, 59909, Germany

Location

St. Antonius Krankenhaus, Med. Klinik

Cologne, 50968, Germany

Location

DDZ Deutsches Diabetes Zentrum

Düsseldorf, 40221, Germany

Location

St. Josefs Krankenhaus

Heidelberg, 69115, Germany

Location

Praxisklinik Leipzig

Leipzig, 04103, Germany

Location

Praxis Dr. Gerhard Willms

Leverkusen, 51373, Germany

Location

Praxis Dr. Heinz-Georg Ley

Marl, 45770, Germany

Location

Diabetologische Schwerpunktpraxis, Angiologie

Münster, 48145, Germany

Location

Praxis Dr. Werner Stürmer

Würzburg, 97070, Germany

Location

Related Publications (3)

  • 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.

    PMID: 23991111DERIVED

  • 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.

    PMID: 22448235DERIVED

  • 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.

    PMID: 21412424DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Stefan Martin, MD

    DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

March 1, 2004

Primary Completion

January 1, 2008

Study Completion

March 1, 2009

Last Updated

June 19, 2017

Record last verified: 2017-06

Locations

DE(12)