A clinical trial in adults with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on the preservation of beta-cell functio

Phase 1

• Conditions: Type 1 diabetes mellitus(T1DM); MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2020-000435-45-IT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-07
• Last Update Posted: 6 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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 =200 pmol/L measured at screening
• Be willing to comply with intensive diabetes management
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified