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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.
EU CTIS ID: 2024-515234-33-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 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
- 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).
- Atrioventricular block first degree (>320ms).
- Current use of ß-blockers.
- Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results.
See the full eligibility criteria
- 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).
- 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
- 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).
- Atrioventricular block first degree (>320ms).
- Current use of ß-blockers.
- Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results.
- Have any complicating medical issues or history that may interfere with the study conduct, as judged by the investigator.
- Have persistent history of malignancies other than skin.
- 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).
- Known hypersensitivity to Verapamil SR or to any of its excipients.
- Concomitant medication known for inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism.
- Intake of grapefruit juice, licorice, St. John’s Wort, cannabidiol, ginkgo biloba.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.