Phase 2
N=40
Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00529191 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus — 345; 178 nanogram*minutes/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Atorvastatin (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of a Daily Dose of Atorvastatin to Maintain Islet Cell Function as Measured by a 4-hour C-peptide Area Under Curve (AUC) in Patients With Newly Diagnosed Type 1 Diabetes Mellitus |
345; 178 | — |
| SECONDARY % Subjects Without Change in 2-hour C-peptide AUC in Response to the MMTT at Baseline vs. 12 Months |
14.8; 38.4 | — |
| SECONDARY Mean Daily Insulin Dose Per kg Body Weight for 7 Days |
0.53; 0.62; 0.50; 0.52; 0.48; 0.50 | — |
| SECONDARY Levels of HbA1c at Months 3, 6, 9, 12 and 18 |
6.68; 6.39; 7.13; 6.62; 7.47; 6.86 | — |
| SECONDARY Blood Glucose Control (Number of Participants With Hypoglycemia) |
16; 7; 16; 9; 8; 8 | — |
| SECONDARY Number of Episodes of Hypoglycemia Requiring Any Treatment |
4.13; 2.86; 3.44; 2.44; 2.75; 2.5 | — |
| SECONDARY Study Drug Compliance Rate Overall |
85.1; 76.9 | — |
| SECONDARY HDL and LDL Cholesterol Levels in Participants Stratified by the Preservation of Islet Cell Function |
47.58; 44.75; 47.33; 53.2; 99.04; 96.13 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00529191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.