Targeting Beta Cell Dysfunction With Verapamil in Longstanding T1D

NCT ID: NCT05847413

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-30
• Study Completion Date: 2021-12-10

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Targeting Beta cell Dysfunction with Verapamil in Longstanding T1D

Participants will receive verapamil for 12 weeks

Group Type: EXPERIMENTAL

Verapamil

Intervention Type: DRUG

Subjects will receive oral verapamil for 12 weeks

Interventions

Verapamil

Subjects will receive oral verapamil for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥ 3 years from Type 1 diabetes diagnosis

2. Males and females 18-50 years of age, inclusive

3. Peak MMTT stimulated C-peptide < 0.017 pmol/mL

4. Females of child-bearing potential must be willing to use effective birth control for 12 weeks

5. Willing and able to give informed consent for participation

6. 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carla Greenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Benaroya Research Institute

Locations

Benaroya Research Institute

Seattle, Washington, United States

Countries

United States

References

Lord SM, Bahnson HT, Greenbaum CJ, Liljenquist DR, Virostko J, Speake C. Testing a new platform to screen disease-modifying therapy in type 1 diabetes. PLoS One. 2023 Dec 14;18(12):e0293268. doi: 10.1371/journal.pone.0293268. eCollection 2023.

Reference Type: DERIVED

PMID: 38096190 (View on PubMed)

Other Identifiers

IRB20042

Identifier Type: -

Identifier Source: org_study_id