Type 1 Diabetes Clinical Trial
— TIDMOfficial 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).
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2013 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 19 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Diabetes Center for Children & Clinical Translational Research Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | FDA Office of Orphan Products Development, Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 4-hour C-peptide Area Under the Curve (AUC) in Response to Mixed Meal (MMTT). | 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. The area under the curve from these combined measurements is calculated and the unit of measure is nanogram*minutes/ml. | 0, 30, 60, 90, 120, 150, 180, 210 and 240 minutes | Yes |
Secondary | •2-hour and 4-hour C-peptide AUC After MMTT. •Hemoglobin A1c •Mean Daily Insulin Dose Per kg Body Weight for 7 Days •Mean Blood Glucose (BG), Number of Preprandial BG > 160 mg/dL or < 70 mg/dL, and Postprandial BG >200 mg/dL | for the C-peptide AUC measurements collected over a 2 or 4 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. Mean daily insulin dose is calculated from a logbook maintained by the subjects for one week prior to study visits. |
baseline, 1,3,6,9,12,18 months | No |
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