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Clinical Trial Details

Trial ID: L7280
Source ID: NCT02372253
Associated Drug: Verapamil
Title: Verapamil for Beta Cell Survival Therapy in Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02372253/results
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: Verapamil|DRUG: Placebo
Outcome Measures: Primary: Functional Beta Cell Mass, Functional Beta Cell Mass as determined by the area under the curve (AUC) from a 2-hour Mixed Meal-Stimulated C-peptide after daily verapamil for 12 months. A greater improvement in insulin production (as an indirect measure of beta cell mass) in subjects receiving verapamil as compared to those receiving placebo would provide an indication of the efficacy of this intervention. The C-peptide AUC (0-120 min) was calculated by using the trapezoidal rule and was divided by the time of the test to obtain the mean AUC (in nmol/L)., 12 months | Secondary: Percent Change From Baseline in Exogenous Insulin Requirements, Percent change in exogenous insulin requirements over the last 7-14 consecutive days at 12 months. This will be assessed as a surrogate inverse marker of residual beta cell function., 12 months|Percent Change From Baseline in Exogenous Insulin Requirements, Percent change in exogenous insulin requirements over the last 7-14 consecutive days at 12 weeks. This will be assessed as a surrogate inverse marker of residual beta cell function., 12 weeks|HbA1C, Glycemic control, as measured by HbA1c. In addition to being an important determinant of residual beta cell function/survival, it also helps reveal a more complete picture of beta cell function., 12 months|HbA1c, Glycemic control, as measured by HbA1c. In addition to being an important determinant of residual beta cell function/survival, it also helps reveal a more complete picture of beta cell function., 12 weeks|Hypoglycemic Events, Glycemic control, as measured by hypoglycemic events., 12 months | Other: Beta Cell Markers, Beta cell markers. We will collect serum at baseline and at Week 12 and Months 6, 9 and 12 for future assessment of putative beta cell markers., 12 weeks and 12 months
Sponsor/Collaborators: Sponsor: University of Alabama at Birmingham | Collaborators: Juvenile Diabetes Research Foundation
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 32
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2015-02
Completion Date: 2019-12
Results First Posted: 2019-01-30
Last Update Posted: 2020-02-05
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States
URL: https://clinicaltrials.gov/show/NCT02372253