Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)

Completed · Phase 2 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

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).

Key facts

Study ID

NCT00529191

Run by

Children's Hospital of Philadelphia

People needed

40

Starts

2007-07-01

Expected to finish

2013-07-01

Last updated by the study team

2017-03-13

Who can join

Age: 10 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Diabetes Center for Children & Clinical Translational Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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