Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborators: FDA Office of Orphan Products Development; Medical University of South Carolina
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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,

• Subjects with any illness that might complicate diabetes management or preclude treatment with atorvastatin,

• Transplant recipients,

• Evidence of liver dysfunction or myopathy