Diabetes Mellitus, Type 1Phase 2Ver-A-T1DNCT04545151
Verapamil SR in Adults With Type 1 Diabetes
A Phase 2 study testing Verapamil SR 120 mg in people with Diabetes Mellitus, Type 1, run by Medical University of Graz at 22 sites in 6 countries.
Trial summary
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Verapamil SR 120 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 22 sitesin 6 countries
- Study dates
- 8 Feb 2021to 17 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have given written informed consent
- 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
Who cannot join
- Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL)
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
22 sites in 6 countries.
22 sites in 6 countries
United Kingdom12 sites
Queen Elizabeth Hospital
Birmingham
Southmead Hospital
Bristol
Addenbrokes Hospital
Cambridge
University Hospital of Wales
Cardiff
NHS Greater Glasgow and Clyde-Queen Elizabeth University Hospital, Department of Diabetes
Glasgow
Bart's Hospital QMUL
London
Guy's Hospital
London
Queens Medical Centre
Nottingham
John Radcliffe Hospital
Oxford
OCDEM, John Radcliffe Hospital
Oxford
Royal Hallamshire Hospital
Sheffield
Singleton Hospital
Swansea
Belgium4 sites
Universitair Ziekenhuis Brussel
Brussels
Université Libre de Bruxelles/ Hôpital Erasme
Brussels
Universitair Ziekenhuis Antwerpen
Edegem
Katholieke Universiteit Leuven
Leuven
Italy2 sites
Università Vita-Salute San Raffaele
Milan
Università degli Studi di Siena
Siena
Austria1 site
Medical University of Graz, Department of Internal Medicine Division of Endocrinology and Metabolism
Graz, Styria, 8010
About this study
Official title: A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of Verapamil SR on Preservation of Beta-cell Function (Ver-A-T1D)
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D).
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.
Read the detailed description
The study is a multicenter, randomized, double-blind, placebo-controlled study in volunteers with newly diagnosed diabetes mellitus type 1 (within 6 weeks after diagnosis).
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
- Diabetes Mellitus, Type 1
- Being tested
- Verapamil SR 120 mg, Placebo
- Keywords
- INNODIA, Typ-1 Diabetes, Verapamil, Beta cell, C-peptide
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verapamil SR 120 mgDrug
Also called VeraHEXAL KHK 120 mg, Isoptin retard 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
PlaceboDrug
Also called Matching Placebo for Verapamil SR 120 mg
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
| Study group | Role | What they receive |
|---|---|---|
| Verapamil SR | Experimental | 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. Receives: Drug: Verapamil SR 120 mg |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the stimulated C-peptide response curve
The primary objective is to determine the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) at baseline and after 12 months for 360mg Verapamil SR administered orally once daily versus placebo.
Measured: At 12 months
Secondary outcomes (10)
Area under the stimulated C-peptide response curve
The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT)
Measured: At 3, 6, 9 and 24 months
Proinsulin, Insulin, Pro-IAPP and Proglucagon secretion
Proinsulin, Insulin, Pro-IAPP and Proglucagon secretion during the first two hours of a mixed meal tolerance test (MMTT)
Measured: At baseline and 3, 6, 9 and 12 months
Fasting C-peptide
To determine the effects of 360mg Verapamil SR administered orally once daily on fasting C-peptide and Dried Blood Spot (DBS) C-peptide measurements over time.
Measured: At 12 months
DBS C-peptide
The DBS (Dried blood spot) C-peptide measurements at all observation times
Measured: At baseline, week 4, week 8, and 3, 6, and 9 months
Change in HbA1c
To determine the effects of 360mg Verapamil SR administered orally once daily on HbA1c daily total insulin dose and continous glucose monitoring (CGM) time in range.
Measured: Baseline, 12 and 24 months
Severe hypoglycaemic episodes
Number of treatment emergent severe hypoglycaemic episodes. Severe hypoglycaemia denotes severe cognitive impairment requiring external assistance for recovery according to the American Diabetes Association (ADA)
Measured: Baseline to 12 months
DKA
Number of treatment emergent episodes of diabetic ketoacidosis
Measured: Baseline to 12 months
Change in insulin requirements
Change in insulin requirements, baseline to 12 months as the daily total dose (three days average) in units per kg body weight (BW)
Measured: Baseline, 12 and 24 months
Change in T1D associated autoantibodies
Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A) from baseline to 12 months
Measured: Baseline to 12 months
Continous glucose monitoring (CGM)
Continous glucose monitoring (CGM) time in range (70-140 mg/dL, 3.9-7.8 mmol/L) and (70-180 mg/dL, 3.9-10.0 mmol/L), time above range (>180 mg/dL, >10.0 mmol/L), time below range (<70 mg/dL, < 3.9 mmol/L)
Measured: At Baseline and every 2 weeks prior to each visit (week 4, week 8, and 3, 6, and 9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start8 Feb 2021
- Primary completion23 Apr 2025
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Thomas R. Pieber, MD, Prof, Principal investigator, Medical University of GrazDayan Colin, MD, Prof, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545151
- Sponsor's protocol ID
- Ver-A-T1D
- Other IDs
- 2020-000435-45, 2023-506545-27-00, 2023
- Acronym
- Ver-A-T1D
- Status last verified
- May 2026
- First submitted
- 21 Aug 2020
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 23890997DiMeglio 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.
PubMed 29916386Lachin 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.
PubMed 24089509Sorensen 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.
PubMed 23990516Ovalle 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.
PubMed 29988125Yin 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.
PubMed 28368479Cooper-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.
PubMed 16996868Chen 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.
PubMed 18171713Xu 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.
PubMed 22442301Seaquist 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.
PubMed 23589542Workgroup 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.
PubMed 15855602Wych 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.
PubMed 39613428
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multi-centre Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of Verapamil SR on Preservation of Beta-cell Function (Ver-A-T1D)
- ClinicalTrials.gov ID
- NCT04545151
- Acronym / sponsor ID
- Ver-A-T1D / Ver-A-T1D
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- INNODIA, Typ-1 Diabetes, Verapamil, Beta cell, C-peptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D).
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.
Detailed description
The study is a multicenter, randomized, double-blind, placebo-controlled study in volunteers with newly diagnosed diabetes mellitus type 1 (within 6 weeks after diagnosis).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil SR | Experimental | Drug: Verapamil SR 120 mgEligible 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. |
| Placebo | Placebo comparator | Drug: PlaceboEligible 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have given written informed consent
- 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
Key exclusion criteria (20 listed)
- Be immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (< 3,000 leukocytes /µL), neutropenia (<1,500 neutrophils/µL), lymphopenia (<800 lymphocytes/µL), or thrombocytopenia (<100,000 platelets/µL)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verapamil SR 120 mgAlso: VeraHEXAL KHK 120 mg, Isoptin retard 120 mgFor 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 | Drug | Verapamil SR |
| PlaceboAlso: Matching Placebo for Verapamil SR 120 mgThe 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 | Drug | Placebo |
Primary outcome
Area under the stimulated C-peptide response curve
Time frame: At 12 months
The primary objective is to determine the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) at baseline and after 12 months for 360mg Verapamil SR administered orally once daily versus placebo.
10 secondary outcomes
Area under the stimulated C-peptide response curve
Time frame: At 3, 6, 9 and 24 months
Proinsulin, Insulin, Pro-IAPP and Proglucagon secretion
Time frame: At baseline and 3, 6, 9 and 12 months
Fasting C-peptide
Time frame: At 12 months
DBS C-peptide
Time frame: At baseline, week 4, week 8, and 3, 6, and 9 months
Change in HbA1c
Time frame: Baseline, 12 and 24 months
Severe hypoglycaemic episodes
Time frame: Baseline to 12 months
DKA
Time frame: Baseline to 12 months
Change in insulin requirements
Time frame: Baseline, 12 and 24 months
Change in T1D associated autoantibodies
Time frame: Baseline to 12 months
Continous glucose monitoring (CGM)
Time frame: At Baseline and every 2 weeks prior to each visit (week 4, week 8, and 3, 6, and 9 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 23890997Atkinson 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.
- Background: PubMed 29916386DiMeglio 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.
- Background: PubMed 24089509Lachin 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.
- Background: PubMed 23990516Sorensen 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.
- Background: PubMed 29988125Ovalle 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.
- Background: PubMed 28368479Yin 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.
- Background: PubMed 16996868Cooper-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.
- Background: PubMed 18171713Chen 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.
- Background: PubMed 22442301Xu 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.
- Background: PubMed 23589542Seaquist 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.
- Background: PubMed 15855602Workgroup 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.
- Derived from this study: PubMed 39613428Wych 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas R. Pieber, MD, Prof principal investigator
Medical University of Graz
Dayan Colin, MD, Prof principal investigator
Cardiff University
22 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Verapamil SR 120 mg in people with Diabetes Mellitus, Type 1, run by Medical University of Graz at 22 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United Kingdom, Belgium, Germany, Italy, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the stimulated C-peptide response curve (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545151, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.