An open-label extension multi-centre trial in adult subjects diagnosed with Type 1 diabetes mellitus exploring the effect of long-term Verapamil SR therapy on the preservation of beta-cell function.

Trial details

Who runs it

Medical University Of Graz

Trial code

EU 2024-515234-33-00

Record updated

2026. szeptember 25.

Original description

To determine the change in Beta-cell function in type 1 diabetes patients measured by C-peptide response to a mixed-meal tolerance test (MMTT) at baseline and after 24 months for 360 mg Verapamil SR administered orally once daily. This will be assessed separately in those with a fasting C-peptide ≥ 50 pmol/L previously treated with a) placebo or b) Verapamil SR for 12 months in the Ver-A-T1D trial.Read full original descriptionShow less

To determine the change in Beta-cell function in type 1 diabetes patients measured by C-peptide response to a mixed-meal tolerance test (MMTT) at baseline and after 24 months for 360 mg Verapamil SR administered orally once daily. This will be assessed separately in those with a fasting C-peptide ≥ 50 pmol/L previously treated with a) placebo or b) Verapamil SR for 12 months in the Ver-A-T1D trial.

Inclusion: 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-AT1D 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); Have given written informed consent (Ver-A-Long); Age ≥18 years at consent; 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: Concomitant medication known for inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism; Hypotension (of less than 90 mmHg systolic), sick sinus syndrome (except patients with a functioning artificial pacemaker), uncompensated heart failure or severe left ventricular dysfunction, marked bradycardia (less than 45 beats/minute), atrioventricular block second or third degree, atrial flutter or atrial fibrillation in the presence of an accessory bypass tract (e.g. Wolff-Parkinson-White syndrome), hypertrophic cardiomyopathy, acute myocardial infarction, attenuated neuromuscular transmission (e.g. by myasthenia gravis, Lambert-Eaton syndrome, advanced Duchenne muscular dystrophy); Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results; Have persistent history of malignancies other than skin; Known hypersensitivity to Verapamil SR or to any of its excipients; 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; History of renal insufficiency or evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal; Current use of calcium channel blockers (except IMP administrated in the Ver-A-T1D trial); Be currently pregnant, lactating or anticipate getting pregnant during the 24 months study period; Substrate intake of CYP3A4 and/or glycoprotein-P metolism, as judged by the investigator; Atrioventricular block first degree (>320ms); Current use of ß-blockers; Have any complicating medical issues or history that may interfere with the study conduct, as judged by the investigator; Intake of grapefruit juice, licorice, St. John’s Wort, cannabidiol, ginkgo biloba.

EU CTIS 2024-515234-33-00