Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

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).
    

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.
    

Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months; One out of three subjects will receive a placebo.
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type I Diabetes (T1DM); Atorvastatin (Lipitor); Insulin; Pancreas; Beta Cells