A clinical trial in adults with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil LP 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-FR
• Lead Sponsor: Medical University of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1/Have given written informed consent
2/Age =18 and <45 years at consent
3/Must have a diagnosis of T1D of within 6 weeks duration at screening (from date of the first insulin injection)
4/Must have at least one or more of the following diabetes-related autoantibodies present at screening: GADA, IA-2A and/or ZnT8A
5/Must have fasting C-peptide levels =100 pmol/L measured at screening
6/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 138
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 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
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