Exploratory effect of long-term Verapamil therapy in adults with Type 1 diabetes mellitus (Ver-A-Long)

Trial ID: ISRCTN49549481

Other - Phase 2 - No longer available

Background and study aims Verapamil SR (sustained release), a medication used for high blood pressure, has been shown to help beta cells in the pancreas produce more insulin. This may help in managing Type 1 diabetes (T1D). Previous studies in animals and humans with newly diagnosed T1D suggest that Verapamil could improve beta-cell function, reduce the need for insulin, and potentially prevent or reverse the disease. The Ver-A-Long study aims to explore whether long-term treatment with Verapamil SR (360 mg daily) can help preserve beta-cell function in adults with T1D and evaluate its safety over 24 months. Who can participate? This study is for adults diagnosed with T1D who are currently participating in the Ver-A-T1D study and have received Verapamil SR or a placebo for 11-12 months. Participants must be aged 18 or older and have a fasting C-peptide level of at least 50 pmol/L. What does the study involve? Participants will take 360 mg of Verapamil SR daily for 24 months, with a gradual increase from 120 mg to 360 mg over the first 3 weeks. They will visit the clinic 6 to 7 times during the study, depending on their entry option, and will also have 4 telephone visits. The study will track the effects of Verapamil on beta-cell function, insulin requirements, blood glucose control, and the occurrence of severe low blood sugar or diabetic ketoacidosis (DKA). Safety will be monitored through vital signs, ECG, and lab tests. What are the possible benefits and risks of participating? Participants may not directly benefit from participating in this study, but the information gathered during their participation could potentially help future patients with Type 1 Diabetes Mellitus. Participants may benefit from having tests, checks and general talks with their study doctor. However, as with any clinical trial, there may be risks, including side effects from the medication or possible complications from low blood sugar or DKA episodes. There are no physical risks to participating other than the usual risks associated with any medication trial. Participants will have access to regular monitoring and safety checks. Where is the study run from? University Hospital of Wales, UK. The trial is being run from seven centres in the UK and six centres in Europe (excluding the UK). When is the study starting and how long is it expected to run for? January 2025 to May 2027. Recruitment started in November 2024 (Europe) and is expected to end by May 2027. Who is funding the study? The study is funded by Breakthrough T1D. Who is the main contact? Prof Colin Dayan, c.m.dayan@bham.ac.uk

Conditions

• Type 1 Diabetes
• Nutritional, Metabolic, Endocrine

Interventions

• Verapamil [Verapamil hydrochloride]

Eligibility

Inclusion criteria

• 1. Be either eligible for Visit 6 of Ver-A-T1D trial on active treatment defined as Placebo or Verapamil SR (240 mg or 360 mg) (option 1) OR have completed V5 of the Ver-A-T1D study and plan to continue with Ver-A-T1D Visit 6 on active treatment defined as Placebo or Verapamil SR (240mg or 360mg) up to 28 days prior to Ver-A-T1D Visit 6 (option 2). 2. Have given written informed consent (Ver-A-Long). 3. Age ≥18 years at consent. 4. Must have fasting C-peptide levels ≥ 50 pmol/L measured at V-1 (according to option 1) or measured at V-2 (according to option 2).

Exclusion criteria

• 1. Be currently pregnant, lactating or anticipate getting pregnant during the 24 months study period. 2. Have any complicating medical issues or history that may interfere with the study conduct, as judged by the investigator. 3. Have persistent history of malignancies other than skin. 4. History of liver insufficiency or laboratory evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal. 5. History of renal insufficiency or evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal. 6. Current use of calcium channel blockers (except IMP administrated in the Ver-A-T1D trial). 7. Known hypersensitivity to Verapamil SR or to any of its excipients. 8. Concomitant medication known for inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism. 9. Intake of grapefruit juice, licorice, St. John’s Wort, cannabidiol, ginkgo biloba. 10. Substrate intake of CYP3A4 and/or glycoprotein-P metabolism, as judged by the investigator.

Sponsor

Medical University of Graz

Source: https://www.isrctn.com/

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