Verapamil SR in Adults With Type 1 Diabetes

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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". (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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborator: Juvenile Diabetes Research Foundation
• Treatments: Verapamil

Criteria

Inclusion Criteria:

• Have given written informed consent

• Age ≥18 and <45 years at consent

• Must have a diagnosis of T1D of within 6 weeks duration at screening (from date of the first insulin injection)

• Must have at least one or more diabetes-related autoantibodies present at screening

• Must have random 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

• Evidence of liver dysfunction with aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 3 times the upper limits of normal

• 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 the excipients, use of beta-blockers in patients with poor ventricular function, concomitant ingestion of grapefruit juice, combination with ivabradine

• Hypotension (of less than 90mmHg systolic), sick sinus syndrome (except in patients with a functioning artificial pacemaker); uncompensated heart failure; marked bradycardia (less than 50 beats/minute), Wolff-Parkinson-White syndrome, acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure

• ECG second or third degree atrioventricular block

• Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results