Type 1 DiabetesPhase 1NCT00974740
DIATOR-Diabetes Intervention With Atorvastatin
A Phase 1 study testing Atorvastatin in people with Type 1 Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 12 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 12 sitesGermany
- Study dates
- Mar 2004to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Diabetes-Zentrum Mergentheim
Bad Mergentheim, 97980
Gemeinschaftskrankenhaus Havelhöhe
Berlin, 14089
Helios Klinikum Emil von Behring
Berlin, 14165
Praxis Dr. Friedhelm Schmitten
Bestwig-Ramsbeck, 59909
St. Antonius Krankenhaus, Med. Klinik
Cologne, 50968
DDZ Deutsches Diabetes Zentrum
Düsseldorf, 40221
St. Josefs Krankenhaus
Heidelberg, 69115
Praxisklinik Leipzig
Leipzig, 04103
Praxis Dr. Gerhard Willms
Leverkusen, 51373
Praxis Dr. Heinz-Georg Ley
Marl, 45770
Diabetologische Schwerpunktpraxis, Angiologie
Münster, 48145
Praxis Dr. Werner Stürmer
Würzburg, 97070
About this study
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 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.
Read the 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
- Conditions
- Type 1 Diabetes
- Being tested
- Atorvastatin, atorvastatin matching placebo
- Keywords
- type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Sortis
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 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)
| Study group | Role | What they receive |
|---|---|---|
| atorvastatin matching placebo | Placebo comparator | atorvastatin matching placebo Receives: 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 Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide after a liquid mixed meal stimulation
Measured: at randomization, after 12 months, and after 18 months of treatment
Secondary outcomes (5)
HbA1c
Measured: at randomization, after 6, 12, and 18 months of treatment
insulin dose
Measured: at randomization, and after 3, 6, 12, and 18 months of treatment
adverse events
Measured: at randomization, and after 3, 6, 12, and 18 months of treatment
serum lipids
Measured: at randomization, and after 3, 6, 12, and 18 months of treatment
plasma CRP
Measured: at randomization, and after 3, 12, and 18 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startMar 2004
- Primary completionJan 2008
- Study completionMar 2009
Why it stopped: for lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Stefan Martin, MD, Principal investigator, DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974740
- Sponsor's protocol ID
- 33/0136-Diator
- Status last verified
- Jun 2017
- First submitted
- 9 Sep 2009
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23991111Strom 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.
PubMed 22448235Martin 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.
PubMed 21412424
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00974740
- Acronym / sponsor ID
- 33/0136-Diator
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: for lack of recruitment
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Mar 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| atorvastatin matching placebo | Placebo comparator | Drug: atorvastatin matching placeboatorvastatin matching placebo |
| atorvastatin | Experimental | Drug: Atorvastatin40 mg atorvastatin for 4 weeks (run-in period), then 80 mg atorvastatin, total treatment period was 18 months |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Sortisatorvastatin 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) | Drug | atorvastatin |
| atorvastatin matching placeboatorvastatin 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) | Drug | atorvastatin matching placebo |
Primary outcome
C-peptide after a liquid mixed meal stimulation
Time frame: at randomization, after 12 months, and after 18 months of treatment
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: for lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
- Derived from this study: PubMed 23991111Kolb 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.
- Derived from this study: PubMed 22448235Strom 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.
- Derived from this study: PubMed 21412424Martin 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.
Related trials for Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Martin, MD principal investigator
DDZ Deutsches Diabetes Zentrum, Düsseldorf, Germany
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Atorvastatin in people with Type 1 Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: for lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-peptide after a liquid mixed meal stimulation (time frame: at randomization, after 12 months, and after 18 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974740, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2017.