Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
NCT00529191 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2017-03-13
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).
Conditions
Interventions
- DRUG
-
Pill, initially at 10 mg, then after 4 weeks, 20 mg Once daily for a total of 12 months
- OTHER
-
Placebo
One out of three subjects will receive a placebo.
Sponsors & Collaborators
-
FDA Office of Orphan Products Development
collaborator FED -
Medical University of South Carolina
collaborator OTHER -
Children's Hospital of Philadelphia
lead OTHER
Principal Investigators
-
Steven M Willi, M.D · Children's Hospital of Philadelphia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2011-07-31
- Completion
- 2013-07-31
Countries
- United States
Study Locations
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