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Clinical Trial Details

Trial ID: L2457
Source ID: NCT00529191
Associated Drug: Atorvastatin
Title: Atorvastatin in New Onset Type 1 Diabetes Mellitus (T1DM)
Acronym: TIDM
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00529191/results
Conditions: Type 1 Diabetes
Interventions: DRUG: Atorvastatin|OTHER: Placebo
Outcome Measures: 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, The change in 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 at baseline vs 12 months post-treatment were calculated. The area under the curve for these combined measurements is calculated and the unit of measure is nanogram x minutes / mL. Efficacy (success) is defined by \< 7.5% reduction in AUC for 4-hr MMTT., Baseline vs 12-month | Secondary: % Subjects Without Change in 2-hour C-peptide AUC in Response to the MMTT at Baseline vs. 12 Months, The C-peptide AUC measurements are collected over a 2 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. The change in C-peptide AUC in response to a 2 hour MMTT at baseline vs 12 months were calculated, and efficacy (success) is defined as \< 7.5% reduction., Baseline vs 12 months|Mean Daily Insulin Dose Per kg Body Weight for 7 Days, Mean daily insulin dose per kg body weight for the 1 week preceding each scheduled study visit., Visit 1, 2, 3, 4, 5, 6, 7|Levels of HbA1c at Months 3, 6, 9, 12 and 18, 3, 6, 9, 12, and 18 months|Blood Glucose Control (Number of Participants With Hypoglycemia), Blood glucose control as determined from home glucose meter downloads for the 1 week preceding the visit. The number of subjects with hypoglycemic episodes requiring treatment (BG \< 70 mg/dl), Baseline, Month 12, Month 18|Number of Episodes of Hypoglycemia Requiring Any Treatment, number of episodes of hypoglycemia requiring any treatment, defined by the need for treatment with glucagon or third party intervention., Baseline, Month 12, Month 18|Study Drug Compliance Rate Overall, Compliance is defined as \>=80% expected dosage consumed during the visit period., 12 months treatment|HDL and LDL Cholesterol Levels in Participants Stratified by the Preservation of Islet Cell Function, Relationship between atorvastatin's effect on HDL and LDL cholesterol and the preservation of islet cell function. Islet cell preservation defined as: \<7.5% Reduction in C-Pep, Baseline, Week 1, Month 3, Month 6, Month 9, Month 12,
Sponsor/Collaborators: Sponsor: Children's Hospital of Philadelphia | Collaborators: FDA Office of Orphan Products Development|Medical University of South Carolina
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-07
Completion Date: 2013-07
Results First Posted: 2013-03-08
Last Update Posted: 2017-03-13
Locations: Diabetes Center for Children & Clinical Translational Research Center, Philadelphia, Pennsylvania, 19104, United States
URL: https://clinicaltrials.gov/show/NCT00529191