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-AT
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Last Update Posted: 2 September 2024

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

•Exclusion Criteria:
1.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)
2.Have active signs or symptoms of acute infection at the time of screening
3.Be currently pregnant or lactating, or anticipate getting pregnant during the 12 months study period
4.Require use of immunosuppressive agents including chronic use of systemic steroids
5.Have evidence of current or past human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection
6.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
7.Have persistent history of malignancies other than skin
8.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
9.History of renal insufficiency or evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal
10.Current or ongoing use of non-insulin pharmaceuticals that affect glycaemic control within prior 7 days of screening
11.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
12.Current use of Verapamil or other calcium channel blockers
13.Known hypersensitivity to Verapamil or to any of its excipients
14.Concomitant medication known for significantly inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism
15.Intake of grapefruit juice, licorice, St.John’s Wort, cannabidiol, ginkgo biloba
16.Substrate intake of CYP3A4 and/or glycoprotein-P metabolism, as judged by the investigator
17.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)
18.ECG second or third degree atrioventricular block; Incomplete branch block.
19.Any condition that in the investigator's opinion may adversely affect study participation or may compromise the study results.
20.Current use of ß-blockers.

Study & Design

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