Type 1 Diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
The Ver-A-Long study involves a single treatment group receiving Verapamil SR, which is administered orally once daily. As this study involves only one treatment group, randomisation is not applicable
Sponsors
Medical University of Graz
Eligibility
Sex/Gender
All
Age
18 Years to 46 Years
Inclusion criteria
Inclusion criteria: 1. Be either eligible for Visit 6 of Ver-A-T1D trial on active treatment defined as Placebo or Verapamil SR (240 mg or 360 mg) (option 1) OR have completed V5 of the Ver-A-T1D study and plan to continue with Ver-A-T1D Visit 6 on active treatment defined as Placebo or Verapamil SR (240mg or 360mg) up to 28 days prior to Ver-A-T1D Visit 6 (option 2). 2. Have given written informed consent (Ver-A-Long). 3. Age =18 years at consent. 4. Must have fasting C-peptide levels = 50 pmol/L measured at V-1 (according to option 1) or measured at V-2 (according to option 2).
Exclusion criteria
Exclusion criteria: 1. Be currently pregnant, lactating or anticipate getting pregnant during the 24 months study period. 2. Have any complicating medical issues or history that may interfere with the study conduct, as judged by the investigator. 3. Have persistent history of malignancies other than skin. 4. 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. 5. History of renal insufficiency or evidence of renal dysfunction with creatinine greater than 1.5 times the upper limit of normal. 6. Current use of calcium channel blockers (except IMP administrated in the Ver-A-T1D trial). 7. Known hypersensitivity to Verapamil SR or to any of its excipients. 8. Concomitant medication known for inducing or inhibiting CYP3A4 and/or glycoprotein-P metabolism. 9. Intake of grapefruit juice, licorice, St. John’s Wort, cannabidiol, ginkgo biloba. 10. Substrate intake of CYP3A4 and/or glycoprotein-P metabolism, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in C-peptide response to a mixed-meal tolerance test (MMTT) in adults diagnosed with T1D receiving 360 mg oral Verapamil SR daily is measured using the area under the curve at baseline (V-1) and at 24 months (V8) of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in C-peptide response to a mixed-meal tolerance test (MMTT) in adults diagnosed with T1D receiving 360 mg oral Verapamil SR daily is measured using the area under the curve at 6 months (V5), 12 months (V6), and 18 months (V7) of therapy. 2. Changes in blood glucose control as assessed by HbA1c in adults diagnosed with T1D receiving 360 mg oral Verapamil daily is measured at baseline (V-1) and at 6 months (V5), 12 months (V6), 18 months (V7), and 24 months (V8) of therapy. 3. Changes in insulin requirements as the total daily insulin dose (seven-day average) in units per kg body weight (BW) in adults diagnosed with T1D receiving 360 mg oral Verapamil daily is measured at baseline (V-1) and at 6 months (V5), 12 months (V6), 18 months (V7), and 24 months (V8) of therapy. 4. The number of treatment-emergent severe hypoglycaemic episodes, defined as severe cognitive impairment requiring external assistance for recovery is measured as per the American Diabetes Association (ADA) criteria. 5. The number of treatment-emergent episodes of diabetic ketoacidosis (DKA) is measured throughout the study period. 6. Adverse events, vital signs variation, ECG, and laboratory safety parameters are measured at baseline (V-1) and at 6 months (V5), 12 months (V6), 18 months (V7), and 24 months (V8) of therapy. | — |
Countries
Austria, Belgium, England, France, Germany, Italy, Scotland, United Kingdom, Wales
Contacts
Public ContactColin Dayan
Outcome results
None listed