Verapamil SR in Adults With Type 1 Diabetes (Ver-A-T1D)

May 18, 2026 updated by: Medical University of Graz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Medical University of Graz, Department of Internal Medicine Division of Endocrinology and Metabolism
  • Belgium
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel
      • Brussels, Belgium
        • Université Libre de Bruxelles/ Hôpital Erasme
      • Edegem, Belgium
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgium
        • Katholieke Universiteit Leuven
  • France
      • Paris, France
        • Institut National de la Santé et de la Recherche Médicale
  • Germany
      • Hanover, Germany
        • HKA Hannover
      • Ulm, Germany
        • Universität Ulm
  • Italy
      • Milan, Italy
        • Università Vita-Salute San Raffaele
      • Siena, Italy
        • Università degli Studi di Siena
  • United Kingdom
      • Birmingham, United Kingdom
        • Queen Elizabeth Hospital
      • Bristol, United Kingdom
        • Southmead Hospital
      • Cambridge, United Kingdom
        • Addenbrokes Hospital
      • Cardiff, United Kingdom
        • University Hospital of wales
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde-Queen Elizabeth University Hospital, Department of Diabetes
      • London, United Kingdom
        • Guy'S Hospital
      • London, United Kingdom
        • Bart's Hospital QMUL
      • Nottingham, United Kingdom
        • Queens Medical Centre
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Oxford, United Kingdom
        • OCDEM, John Radcliffe Hospital
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital
      • Swansea, United Kingdom
        • Singleton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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
Other Names:
  • VeraHEXAL KHK 120 mg
  • Isoptin retard 120 mg
Placebo Comparator: 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.
Drug: 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 Names:
  • Matching Placebo for Verapamil SR 120 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the stimulated C-peptide response curve
Time Frame: At 3, 6, 9 and 24 months
The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT)
At 3, 6, 9 and 24 months
Fasting C-peptide
Time Frame: At 12 months
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.
At 12 months
DBS C-peptide
Time Frame: At baseline, week 4, week 8, and 3, 6, and 9 months
The DBS (Dried blood spot) C-peptide measurements at all observation times
At baseline, week 4, week 8, and 3, 6, and 9 months
Change in HbA1c
Time Frame: Baseline, 12 and 24 months
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.
Baseline, 12 and 24 months
Severe hypoglycaemic episodes
Time Frame: Baseline to 12 months
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)
Baseline to 12 months
DKA
Time Frame: Baseline to 12 months
Number of treatment emergent episodes of diabetic ketoacidosis
Baseline to 12 months
Change in insulin requirements
Time Frame: Baseline, 12 and 24 months
Change in insulin requirements, baseline to 12 months as the daily total dose (three days average) in units per kg body weight (BW)
Baseline, 12 and 24 months
Change in T1D associated autoantibodies
Time Frame: Baseline to 12 months
Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A) from baseline to 12 months
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)
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)
At Baseline and every 2 weeks prior to each visit (week 4, week 8, and 3, 6, and 9 months)
Proinsulin, Insulin, Pro-IAPP and Proglucagon secretion
Time Frame: At baseline and 3, 6, 9 and 12 months
Proinsulin, Insulin, Pro-IAPP and Proglucagon secretion during the first two hours of a mixed meal tolerance test (MMTT)
At baseline and 3, 6, 9 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life: DTSQs questionnaire
Time Frame: At week 4 , month 6 and month 12.

Patients' quality of life will be assessed by participant-reported outcome measures (PROMS):

the Diabetes Treatment Satisfaction Questionnaire - DTSQs
At week 4 , month 6 and month 12.
Quality of life: DTSQc questionnaire
Time Frame: At month 12

Patients' quality of life will be assessed by participant-reported outcome measures (PROMS):

the Diabetes Treatment Satisfaction Questionnaire - DTSQc
At month 12
Quality of life: ADDQoL questionnaire
Time Frame: At month 6 and at month 12

Patients' quality of life will be assessed by participant-reported outcome measures (PROMS):

· the Audit of Diabetes Dependent Quality of Life - ADDQoL
At month 6 and at month 12
Quality of life: HypoFear questionnaire
Time Frame: At week 4 , at month 6 and at month 12
Patients' quality of life will be assessed by participant-reported outcome measures (PROMS): the Hypoglycaemia Fear Survey - HFS
At week 4 , at month 6 and at month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

Juvenile Diabetes Research Foundation

Investigators

  • Principal Investigator: Thomas R. Pieber, MD, Prof, Medical University of Graz
  • Principal Investigator: Dayan Colin, MD, Prof, Cardiff University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Actual)

April 23, 2025

Study Completion (Actual)

April 17, 2026

Study Registration Dates

First Submitted

August 21, 2020

First Submitted That Met QC Criteria

September 7, 2020

First Posted (Actual)

September 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ver-A-T1D
  • 2020-000435-45 (EudraCT Number)
  • 2023-506545-27-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning after publication of the primary results papers reporting the prespecified endpoints described in the Statistical analysis plan. (no end date)

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal - and if needed an ethics approval for the project will be able to access the IPD and supporting information. Access will be provided for research projects to achieve aims in the approved proposal at the level of individual data including for meta-analyses.

Proposals should be directed to the Chief-Investigator (who may consult with other members of the trial team).To gain access, data requestors will need to sign a data access agreement. Data will be made available directly to the person requesting the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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