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NCT02372253 · ClinicalTrials.gov registry record · Phase 2
Verapamil for Beta Cell Survival Therapy in Type 1 Diabetes
A Phase 2 study of Type 1 Diabetes Mellitus, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT02372253: Completed Phase 2 study of Type 1 Diabetes Mellitus, sponsored by University of Alabama at Birmingham.
NCT02372253 is a Phase 2 study of Type 1 Diabetes Mellitus that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 32 participants, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02372253, a Phase 2 study of Type 1 Diabetes Mellitus, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall purpose of this trial is to assess the efficacy and safety of using oral verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the patients' endogenous beta cell mass and insulin production. The objectives are therefore to assess parameters of beta cell survival (including new biomarkers), insulin production and glucose control and the feasibility of this approach and thereby provide the basis for future, larger/expanded, longer-term verapamil studies and the off-label use of this approved drug for Type 1 Diabetes (T1D).
Primary Outcome
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 o
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Verapamil
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-02 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
What the finished NCT02372253 record still lists
NCT02372253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 172-participant average among 112 other Type 1 Diabetes Mellitus trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02372253 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT02372253 about?
NCT02372253 is a clinical study titled "Verapamil for Beta Cell Survival Therapy in Type 1 Diabetes". The overall purpose of this trial is to assess the efficacy and safety of using oral verapamil in subjects with recent onset T1D in order to downregulate TXNIP and enhance the patients' endogenous beta cell mass and insulin production. The objectives are therefore to assess parameters of beta cell s...
What is the current status of trial NCT02372253?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2015-02. Estimated completion is 2019-12.
What conditions does trial NCT02372253 study?
This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.
What interventions are being tested in trial NCT02372253?
The interventions under investigation include: Placebo (DRUG), Verapamil (DRUG).
Who is sponsoring clinical trial NCT02372253?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02372253 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02372253's enrollment target sits among peer trials
32 68th of 112 higher than 42 of 112 other Type 1 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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