Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
138 participants
INTERVENTIONAL
2021-02-08
2026-05-31
Brief Summary
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For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.
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Detailed Description
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The purpose of the clinical trial is to confirm the effect of 360mg Verapamil sustained release (SR) administered orally once daily (titrated over the first 3 months from 120 mg to 360 mg) on the preservation of beta-cell function measured as stimulated C-peptide after 12 months compared to placebo.
The study has a cross-over design and a duration of approximately 24 months, consisting of 3 telephone visits and 7 visits at the trial site. The duration of the treatment phase with verapamil is 12 months, and an additional (optional) follow-up visit will be carried out 12 months after completion of the study. The study procedures are identical in all 20 clinical centres across Europe and the UK.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Verapamil SR
Eligible participants will be randomised into the Verapamil SR arm and receive instructions on frequency of administration (daily intake). 80 participants on the experimental arm are expected to complete the trial.
Verapamil SR 120 mg
For use as a test product in this blinded study, the IMP will be modified by re-packaging. The film-coated tablets will be squeezed from their blisters and filled into HDPE Twist-Off bottles. Each bottle will be labeled as required per country requirement. Labels will be blinded.
Drug administration:
* from Day 0 to Week 4: 120 mg once daily
* from Week 4 to Week 8: 240 mg once daily
* from Week 8 to Month 12: 360 mg once daily
Placebo
Eligible participants will be randomised into the placebo arm and receive instructions on frequency of administration (daily intake).
40 participants on the control arm are expected to complete the trial.
Placebo
The matching placebo will be filled into HDPE Twist-Off bottles, in the same way as the verum. Each bottle will be labeled as required per country requirement. Labels will be blinded.
Drug administration:
* from Day 0 to Week 4: 120 mg once daily
* from Week 4 to Week 8: 240 mg once daily
* from Week 8 to Month 12: 360 mg once daily
Interventions
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Verapamil SR 120 mg
For use as a test product in this blinded study, the IMP will be modified by re-packaging. The film-coated tablets will be squeezed from their blisters and filled into HDPE Twist-Off bottles. Each bottle will be labeled as required per country requirement. Labels will be blinded.
Drug administration:
* from Day 0 to Week 4: 120 mg once daily
* from Week 4 to Week 8: 240 mg once daily
* from Week 8 to Month 12: 360 mg once daily
Placebo
The matching placebo will be filled into HDPE Twist-Off bottles, in the same way as the verum. Each bottle will be labeled as required per country requirement. Labels will be blinded.
Drug administration:
* from Day 0 to Week 4: 120 mg once daily
* from Week 4 to Week 8: 240 mg once daily
* from Week 8 to Month 12: 360 mg once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 and \<45 at consent
* Must have a diagnosis of T1D of within 6 weeks duration at screening (date of the first insulin injection)
* Must have at least one or more diabetes-related autoantibodies present at screening: GADA, IA-2A and/or ZnT8A
* Must have fasting C-peptide levels ≥100 pmol/L measured at screening
* Be willing to comply with intensive diabetes management
Exclusion Criteria
* Have active signs or symptoms of acute infection at the time of screening
* Be currently pregnant or lactating, or anticipate getting pregnant during the 12 months study period
* Require use of immunosuppressive agents including chronic use of systemic steroids
* Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
* Have any complicating medical issues or abnormal clinical laboratory results that may interfere with study conduct, or cause increased risk to include pre-existing cardiac disease, chronic obstructive pulmonary disease (COPD), sickle cell disease, neurological, or blood count abnormalities as judged by the investigator
* Have a 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 or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within prior 7 days of screening
* Use of any other investigational drug in the previous 30 days and/or intent on using any investigational drug for the duration of the trial
* Current use of Verapamil or other calcium channel blockers
* Known hypersensitivity to Verapamil or to any of its excipients
* Concomitant medication known for significantly inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism
* Intake of grapefruit juice, licorice, St.John's Wort, cannabidiol, ginkgo biloba
* Substrate intake of CYP3A4 and/or glycoprotein-P metabolism, as judged by the investigator
* Hypotension (of less than 100mmHg systolic), sick sinus syndrome (except patients with a functioning artificial pacemaker), uncompensated heart failure or severe left ventricular dysfunction; marked bradycardia (less than 50 beats/minute), 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)
* ECG second or third degree atrioventricular block; Incomplete branch block
* Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results
* Current use of ß-blockers
18 Years
45 Years
ALL
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
Medical University of Graz
OTHER
Responsible Party
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Principal Investigators
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Thomas R. Pieber, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Dayan Colin, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Cardiff University
Locations
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Medical University of Graz, Department of Internal Medicine Division of Endocrinology and Metabolism
Graz, Styria, Austria
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Université Libre de Bruxelles/ Hôpital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Katholieke Universiteit Leuven
Leuven, , Belgium
Institut National de la Santé et de la Recherche Médicale
Paris, , France
HKA Hannover
Hanover, , Germany
Universität Ulm
Ulm, , Germany
Università Vita-Salute San Raffaele
Milan, , Italy
Università degli Studi di Siena
Siena, , Italy
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Addenbrokes Hospital
Cambridge, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
NHS Greater Glasgow and Clyde-Queen Elizabeth University Hospital, Department of Diabetes
Glasgow, , United Kingdom
Bart's Hospital QMUL
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Queens Medical Centre
Nottingham, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
OCDEM, John Radcliffe Hospital
Oxford, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
Countries
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References
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Atkinson MA, Eisenbarth GS, Michels AW. Type 1 diabetes. Lancet. 2014 Jan 4;383(9911):69-82. doi: 10.1016/S0140-6736(13)60591-7. Epub 2013 Jul 26.
DiMeglio LA, Evans-Molina C, Oram RA. Type 1 diabetes. Lancet. 2018 Jun 16;391(10138):2449-2462. doi: 10.1016/S0140-6736(18)31320-5.
Lachin JM, McGee P, Palmer JP; DCCT/EDIC Research Group. Impact of C-peptide preservation on metabolic and clinical outcomes in the Diabetes Control and Complications Trial. Diabetes. 2014 Feb;63(2):739-48. doi: 10.2337/db13-0881. Epub 2013 Oct 2.
Sorensen JS, Johannesen J, Pociot F, Kristensen K, Thomsen J, Hertel NT, Kjaersgaard P, Brorsson C, Birkebaek NH; Danish Society for Diabetes in Childhood and Adolescence. Residual beta-Cell function 3-6 years after onset of type 1 diabetes reduces risk of severe hypoglycemia in children and adolescents. Diabetes Care. 2013 Nov;36(11):3454-9. doi: 10.2337/dc13-0418. Epub 2013 Aug 29.
Ovalle F, Grimes T, Xu G, Patel AJ, Grayson TB, Thielen LA, Li P, Shalev A. Verapamil and beta cell function in adults with recent-onset type 1 diabetes. Nat Med. 2018 Aug;24(8):1108-1112. doi: 10.1038/s41591-018-0089-4. Epub 2018 Jul 9.
Yin T, Kuo SC, Chang YY, Chen YT, Wang KK. Verapamil Use Is Associated With Reduction of Newly Diagnosed Diabetes Mellitus. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2604-2610. doi: 10.1210/jc.2016-3778.
Cooper-Dehoff R, Cohen JD, Bakris GL, Messerli FH, Erdine S, Hewkin AC, Kupfer S, Pepine CJ; INVEST Investigators. Predictors of development of diabetes mellitus in patients with coronary artery disease taking antihypertensive medications (findings from the INternational VErapamil SR-Trandolapril STudy [INVEST]). Am J Cardiol. 2006 Oct 1;98(7):890-4. doi: 10.1016/j.amjcard.2006.04.030. Epub 2006 Aug 7.
Chen J, Saxena G, Mungrue IN, Lusis AJ, Shalev A. Thioredoxin-interacting protein: a critical link between glucose toxicity and beta-cell apoptosis. Diabetes. 2008 Apr;57(4):938-44. doi: 10.2337/db07-0715. Epub 2008 Jan 2.
Xu G, Chen J, Jing G, Shalev A. Preventing beta-cell loss and diabetes with calcium channel blockers. Diabetes. 2012 Apr;61(4):848-56. doi: 10.2337/db11-0955.
Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo-Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013 May;36(5):1384-95. doi: 10.2337/dc12-2480. Epub 2013 Apr 15.
Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
Wych J, Brunner M, Stenson R, Chmura PJ, Danne T, Mander AP, Mathieu C, Dayan C, Pieber TR. Investigating the effect of verapamil on preservation of beta-cell function in adults with newly diagnosed type 1 diabetes mellitus (Ver-A-T1D): protocol for a randomised, double-blind, placebo-controlled, parallel-group, multicentre trial. BMJ Open. 2024 Nov 28;14(11):e091597. doi: 10.1136/bmjopen-2024-091597.
Other Identifiers
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2020-000435-45
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
Ver-A-T1D
Identifier Type: -
Identifier Source: org_study_id
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