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Clinical Trials/NCT05847413
NCT05847413CompletedEarly Phase 1

Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D

Benaroya Research Institute1 site in 1 country10 target enrollmentStarted: May 30, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL at 12 weeks.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine whether verapamil can transiently improve beta cell function in those who do or do not secrete proinsulin and little/no C-peptide.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •≥ 3 years from Type 1 diabetes diagnosis
  • •Males and females 18-50 years of age, inclusive
  • •Peak MMTT stimulated C-peptide < 0.017 pmol/mL
  • •Females of child-bearing potential must be willing to use effective birth control for 12 weeks
  • •Willing and able to give informed consent for participation
  • •HbA1c ≤ 8.5%

Exclusion Criteria

  • •Concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of initial qualifying MMTT (V-2).
  • •Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT or AST> 1.5 x the upper limit of age-determined normal (ULN).
  • •Renal disease, as defined by creatinine ≥1.5 mg/dL.
  • •Hypersensitivity to verapamil or any component of the formulation.
  • •Previous use of verapamil.
  • •Known left ventricular dysfunction; bradycardia (HR <50 BPM) 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)
  • •Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease or other serious cardiac disease as described in New York Heart Association (NYHA) Class III or IV criteria within the 12 weeks before randomization.
  • •Use of beta blockers or medium-high dose statins: any dose of atorvastatin (Lipitor) or rosuvastatin (Crestor); simvastatin > 10 mg daily; lovastatin > 20 mg; pravastatin > 20 mg
  • •Use of other medications which may increase the concurrent risk of verapamil use, including medications which utilize the cytochrome p450 enzyme pathway.
  • •Females who are pregnant or lactating.
  • •Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment.
  • •History of other clinically significant autoimmune disease except for celiac and stable thyroid disease.
  • •Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin).
  • •Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial. Conditions to consider include history of chronic GERD, chronic constipation, and chronic nausea.
  • •Specific to MRI subjects: non-removable ferromagnetic materials or MRI not technically feasible (claustrophobia, movement disorder, obesity).

Arms & Interventions

Targeting Beta cell Dysfunction with Verapamil in Longstanding T1D

Experimental

Participants will receive verapamil for 12 weeks

Intervention: Verapamil (Drug)

Outcomes

Primary Outcomes

Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL at 12 weeks.

Time Frame: 0-12 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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