| Trial ID: | L7378 |
| Source ID: | NCT04545151
|
| Associated Drug: |
Verapamil Sr 120 Mg
|
| Title: |
Verapamil SR in Adults With Type 1 Diabetes
|
| Acronym: |
Ver-A-T1D
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 1
|
| Interventions: |
DRUG: Verapamil SR 120 mg|DRUG: Placebo
|
| Outcome Measures: |
Primary: Area under the stimulated C-peptide response curve, The primary objective is to determine the changes in stimulated C-peptide response during the first two hours of a mixed meal tolerance test (MMTT) at baseline and after 12 months for 360mg Verapamil SR administered orally once daily versus placebo., At 12 months | Secondary: Area under the stimulated C-peptide response curve, The area under the stimulated C-peptide response curve over the first two hours of a mixed meal tolerance test (MMTT), At 3, 6, 9 and 24 months|Proinsulin, Insulin, Pro-IAPP and Proglucagon secretion, Proinsulin, Insulin, Pro-IAPP and Proglucagon secretion during the first two hours of a mixed meal tolerance test (MMTT), At baseline and 3, 6, 9 and 12 months|Fasting C-peptide, To determine the effects of 360mg Verapamil SR administered orally once daily on fasting C-peptide and Dried Blood Spot (DBS) C-peptide measurements over time., At 12 months|DBS C-peptide, The DBS (Dried blood spot) C-peptide measurements at all observation times, At baseline, week 4, week 8, and 3, 6, and 9 months|Change in HbA1c, To determine the effects of 360mg Verapamil SR administered orally once daily on HbA1c daily total insulin dose and continous glucose monitoring (CGM) time in range., Baseline, 12 and 24 months|Severe hypoglycaemic episodes, Number of treatment emergent severe hypoglycaemic episodes. Severe hypoglycaemia denotes severe cognitive impairment requiring external assistance for recovery according to the American Diabetes Association (ADA), Baseline to 12 months|DKA, Number of treatment emergent episodes of diabetic ketoacidosis, Baseline to 12 months|Change in insulin requirements, Change in insulin requirements, baseline to 12 months as the daily total dose (three days average) in units per kg body weight (BW), Baseline, 12 and 24 months|Change in T1D associated autoantibodies, Change in T1D associated autoantibodies (GADA, IAA, IA-2A and ZnT8A) from baseline to 12 months, Baseline to 12 months|Continous glucose monitoring (CGM), Continous glucose monitoring (CGM) time in range (70-140 mg/dL, 3.9-7.8 mmol/L) and (70-180 mg/dL, 3.9-10.0 mmol/L), time above range (\>180 mg/dL, \>10.0 mmol/L), time below range (\<70 mg/dL, \< 3.9 mmol/L), At Baseline and every 2 weeks prior to each visit (week 4, week 8, and 3, 6, and 9 months) | Other: Quality of life: DTSQs questionnaire, Patients' quality of life will be assessed by participant-reported outcome measures (PROMS): the Diabetes Treatment Satisfaction Questionnaire - DTSQs, At week 4 , month 6 and month 12.|Quality of life: DTSQc questionnaire, Patients' quality of life will be assessed by participant-reported outcome measures (PROMS): the Diabetes Treatment Satisfaction Questionnaire - DTSQc, At month 12|Quality of life: ADDQoL questionnaire, Patients' quality of life will be assessed by participant-reported outcome measures (PROMS): · the Audit of Diabetes Dependent Quality of Life - ADDQoL, At month 6 and at month 12|Quality of life: HypoFear questionnaire, Patients' quality of life will be assessed by participant-reported outcome measures (PROMS): the Hypoglycaemia Fear Survey - HFS, At week 4 , at month 6 and at month 12
|
| Sponsor/Collaborators: |
Sponsor: Medical University of Graz | Collaborators: Juvenile Diabetes Research Foundation
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
138
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-02-08
|
| Completion Date: |
2026-05
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-30
|
| Locations: |
Medical University of Graz, Department of Internal Medicine Division of Endocrinology and Metabolism, Graz, Styria, 8010, Austria|Universitair Ziekenhuis Brussel, Brussels, Belgium|Université Libre de Bruxelles/ Hôpital Erasme, Brussels, Belgium|Universitair Ziekenhuis Antwerpen, Edegem, Belgium|Katholieke Universiteit Leuven, Leuven, Belgium|Institut National de la Santé et de la Recherche Médicale, Paris, France|HKA Hannover, Hanover, Germany|Universität Ulm, Ulm, Germany|Università Vita-Salute San Raffaele, Milano, Italy|Università degli Studi di Siena, Siena, Italy|Queen Elizabeth Hospital, Birmingham, United Kingdom|Southmead Hospital, Bristol, United Kingdom|Addenbrokes Hospital, Cambridge, United Kingdom|University Hospital of Wales, Cardiff, United Kingdom|NHS Greater Glasgow and Clyde-Queen Elizabeth University Hospital, Department of Diabetes, Glasgow, United Kingdom|Bart's Hospital QMUL, London, United Kingdom|Guy's Hospital, London, United Kingdom|Queens Medical Centre, Nottingham, United Kingdom|John Radcliffe Hospital, Oxford, United Kingdom|OCDEM, John Radcliffe Hospital, Oxford, United Kingdom|Royal Hallamshire Hospital, Sheffield, United Kingdom|Singleton Hospital, Swansea, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT04545151
|
