Phase 2
Completed N=26
Verapamil for Beta Cell Survival Therapy in Type 1 Diabetes
Source: ClinicalTrials.gov NCT02372253 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Functional Beta Cell Mass — 0.74; 0.46 nmol/L
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Beta Cell Mass |
0.74; 0.46 | — |
| SECONDARY Percent Change From Baseline in Exogenous Insulin Requirements |
5.9; 26.0 | — |
| SECONDARY HbA1C |
6.0; 6.6 | — |
| SECONDARY Hypoglycemic Events |
0.55; 2.72 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must meet all of the following criteria:
- Diagnosis of Type 1a Diabetes Mellitus based on American Diabetes Association (ADA) Criteria
- Written informed consent obtained from the subject including consent for the use of research-related health information
- ≥ 18 years of age and ≤ 45 years of age
- 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 x ULN
- A psychiatric or medical disorder that would prevent giving informed consent
- Hypersensitivity to verapamil or any component of the formulation; known left ventricular dysfunction; hypotension (systolic pressure <90 mm Hg); PR interval prolongation on EKG or any bradyarrhythmia (e.g. sick sinus syndrome, Anterior Ventral (AV) block); atrial flutter or fibrillation, and an accessory bypass tract (Wolff-Parkinson- White (WPW) syndrome, Lown-Ganong-Levine syndrome)
Data sourced from ClinicalTrials.gov (NCT02372253). 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. Informational only — not medical advice.