Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D

Sponsor

Benaroya Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT05847413

Collaborator

(none)

Enrollment

Location

Arm

18.4

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: Verapamil	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

open label proof of concept studyopen label proof of concept study

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D

Actual Study Start Date :

May 30, 2020

Actual Primary Completion Date :

Dec 10, 2021

Actual Study Completion Date :

Dec 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Targeting Beta cell Dysfunction with Verapamil in Longstanding T1D Participants will receive verapamil for 12 weeks	Drug: Verapamil Subjects will receive oral verapamil for 12 weeks

Arm

Intervention/Treatment

Experimental: Targeting Beta cell Dysfunction with Verapamil in Longstanding T1D

Participants will receive verapamil for 12 weeks

Drug: Verapamil

Subjects will receive oral verapamil for 12 weeks

Outcome Measures

Primary Outcome Measures

Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL at 12 weeks. [0-12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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). 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). 3. Renal disease, as defined by creatinine ≥1.5 mg/dL. 4. Hypersensitivity to verapamil or any component of the formulation. 5. Previous use of verapamil. 6. 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) 7. 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. 8. 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 9. Use of other medications which may increase the concurrent risk of verapamil use, including medications which utilize the cytochrome p450 enzyme pathway. 10. Females who are pregnant or lactating. 11. Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment. 12. History of other clinically significant autoimmune disease except for celiac and stable thyroid disease. 13. Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin). 14. 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. 15. Specific to MRI subjects: non-removable ferromagnetic materials or MRI not technically feasible (claustrophobia, movement disorder, obesity).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benaroya Research Institute	Seattle	Washington	United States	98101

Sponsors and Collaborators

Benaroya Research Institute

Investigators

Principal Investigator: Carla Greenbaum, MD, Benaroya Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benaroya Research Institute

ClinicalTrials.gov Identifier:

NCT05847413

Other Study ID Numbers:

IRB20042

First Posted:

May 6, 2023

Last Update Posted:

May 6, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1

Verapamil

Study Results

No Results Posted as of May 6, 2023