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Type 1 DiabetesPhase 2TIDMNCT00529191

Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)

A Phase 2 study testing Atorvastatin in people with Type 1 Diabetes, run by Children's Hospital of Philadelphia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM). Read more about this study

Who is it for?
Ages 10 to 19 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
40 participants
Where
1 siteUnited States
Study dates
Jul 2007to Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 10 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Individuals 10-19 years of age (Tanner Stage II or greater),
  • The presence of one or more serum antibodies to islet cell proteins (anti- glutamic acid decarboxylase [GAD], islet antigen 2 or insulin autoantibodies) as assessed in standard practice,
  • Diagnosis of T1DM within the 8 weeks prior to study entry
  • Peak stimulated C-peptide level >0.2pmol/mL following mixed meal tolerance test (MMTT) performed at least 3 weeks after diagnosis,
  • Females of reproductive potential must not plan on conceiving a child during the treatment program, and agree to use a medically accepted form of contraception

Who cannot join

  • Subjects currently receiving cyclosporine, fibric acid derivatives, niacin (nicotinic acid), erythromycin, clarythromycin, nefazodone, itraconazole, ketoconazole or protease inhibitors,
  • Pregnancy or breast-feeding,
  • Clinical AIDS, AIDS related syndrome (ARS) or known positive HIV serology,
  • Subjects treated with immunosuppressive therapy in the past 12 months,
  • Subjects receiving glucocorticoid therapy or therapy other than insulin that is likely to affect glucose homeostasis (such as sulfonylureas, thiazolidinediones, metformin or amylin),
  • Subjects with other autoimmune diseases, except autoimmune thyroid disease,
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  • Subjects with any illness that might complicate diabetes management or preclude treatment with atorvastatin,
  • Transplant recipients,
  • Evidence of liver dysfunction or myopathy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Diabetes Center for Children & Clinical Translational Research Center

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase II, Double Blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Atorvastatin in Subjects With Newly Diagnosed Type 1 Diabetes Mellitus.

The goal of this application is to evaluate the safety and efficacy of atorvastatin as a potential treatment to preserve beta cell function in children and young adults with newly diagnosed type 1 diabetes (T1DM).

Read the detailed description

Type 1 diabetes is an autoimmune disease that is characterized by destruction of the insulin-producing beta cells of the pancreas. T1DM therapy requires insulin administration, either by multiple daily injections or by insulin pump. However, in many patients, blood sugar control remains suboptimal and complications develop that shorten life expectancy and severely impact quality of life. At the time of diagnosis, most patients still have significant residual beta cell function. Previous research has shown that weakening the immune system's attack on the pancreatic beta cells may help to preserve or potentially increase insulin production.

Preliminary studies have shown that members of the statin family of medications, including atorvastatin (Lipitor®), preserve beta cell function in a mouse model of type 1 diabetes. These finding suggest that use of atorvastatin in combination with insulin therapy may delay and potentially reverse the destruction of beta cells in patients who have recently developed type 1 diabetes. Atorvastatin (Lipitor®) is approved for use in adults and children (>10 years of age) who have elevated blood cholesterol levels. This study will examine whether atorvastatin (Lipitor®) may also help the body preserve insulin production in patients with newly diagnosed (within 8 weeks) type 1 diabetes.

Patients will be randomly assigned to take either atorvastatin (Lipitor®) or placebo. Two out of every 3 patients will receive atorvastatin and 1 out of 3 will get placebo. As this is a double-blinded study, neither the care team nor the patient will know if they are actually taking atorvastatin (Lipitor®). Patients who have given consent to participate in the study and pass the required screening tests will take the assigned treatment every day for 12 months. All patients will begin taking 10 mg once daily, the recommended starting dose. After 4 weeks, the dose will be increased to 20 mg. In addition to a high standard of diabetes care and the medication, patients will have blood tests during 7 visits over an 18 month period.

Conditions
Type 1 Diabetes
Being tested
Atorvastatin, Placebo
Keywords
Type I Diabetes (T1DM), Atorvastatin (Lipitor), Insulin, Pancreas, Beta Cells
Medical subject headings
Diabetes Mellitus, Type 1, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called Lipitor

    Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months

  • PlaceboOther

    One out of three subjects will receive a placebo.

Study groups in NCT00529191
Study groupRoleWhat they receive
AtorvastatinExperimentalTwo out of every three patients will receive atorvastatin.
Receives: Drug: Atorvastatin
PlaceboPlacebo comparatorOne out of three subjects will receive a placebo.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus

    The change in C-peptide measurements collected over a 4 hour period (0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes) after a Mixed Meal Tolerance Test at baseline vs 12 months post-treatment were calculated. The area under the curve for these combined measurements is calculated and the unit of measure is nanogram x minutes / mL. Efficacy (success) is defined by < 7.5% reduction in AUC for 4-hr MMTT.

    Measured: Baseline vs 12-month

Secondary outcomes (7)

  1. % Subjects Without Change in 2-hour C-peptide AUC in Response to the MMTT at Baseline vs. 12 Months

    The C-peptide AUC measurements are collected over a 2 hour period (with 30 minute intervals) after a Mixed Meal Tolerance Test. The area under the curve from these combined measurements (from 0 to 120 or 0 to 240 minutes) is calculated and the unit of measure is nanogram*minutes/ml. The change in C-peptide AUC in response to a 2 hour MMTT at baseline vs 12 months were calculated, and efficacy (success) is defined as < 7.5% reduction.

    Measured: Baseline vs 12 months

  2. Mean Daily Insulin Dose Per kg Body Weight for 7 Days

    Mean daily insulin dose per kg body weight for the 1 week preceding each scheduled study visit.

    Measured: Visit 1, 2, 3, 4, 5, 6, 7

  3. Levels of HbA1c at Months 3, 6, 9, 12 and 18

    Measured: 3, 6, 9, 12, and 18 months

  4. Blood Glucose Control (Number of Participants With Hypoglycemia)

    Blood glucose control as determined from home glucose meter downloads for the 1 week preceding the visit. The number of subjects with hypoglycemic episodes requiring treatment (BG < 70 mg/dl)

    Measured: Baseline, Month 12, Month 18

  5. Number of Episodes of Hypoglycemia Requiring Any Treatment

    number of episodes of hypoglycemia requiring any treatment, defined by the need for treatment with glucagon or third party intervention.

    Measured: Baseline, Month 12, Month 18

  6. Study Drug Compliance Rate Overall

    Compliance is defined as >=80% expected dosage consumed during the visit period.

    Measured: 12 months treatment

  7. HDL and LDL Cholesterol Levels in Participants Stratified by the Preservation of Islet Cell Function

    Relationship between atorvastatin's effect on HDL and LDL cholesterol and the preservation of islet cell function.

    Islet cell preservation defined as: <7.5% Reduction in C-Pep

    Measured: Baseline, Week 1, Month 3, Month 6, Month 9, Month 12,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2011
  4. Study completionJul 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00529191
Sponsor's protocol ID
2006-5-4824
Other IDs
R01FD003340
Acronym
TIDM
Status last verified
Jan 2017
First submitted
13 Sep 2007
Last updated
13 Mar 2017
Data monitoring committee
Yes
Individual data sharing
No: There is no plan to share these data, except in aggregate.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atorvastatin in people with Type 1 Diabetes, run by Children's Hospital of Philadelphia at 1 site in United States.

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 5 inclusion and 9 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: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus (time frame: Baseline vs 12-month). 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 NCT00529191.

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 13 Mar 2017.

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