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Clinical Trial Details

Trial ID: L6768
Source ID: NCT04838145
Associated Drug: Ribavirin + Pleconaril
Title: The Diabetes Virus Detection and Intervention Trial
Acronym: DiViDInt
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type1 Diabetes Mellitus|Enterovirus
Interventions: DRUG: Ribavirin + Pleconaril|DRUG: Placebos
Outcome Measures: Primary: Insulin secretion, Change in mean residual insulin secretion in the Insulin tolerance test (ITT)-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to12 months after initiation of study treatment., 12 months | Secondary: Insulin secretion, Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 3 months after initiation of study treatment., 3 months|Insulin secretion, Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 6 months after initiation of study treatment., 6 months|Insulin secretion, Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 24 months after initiation of study treatment., 24 months|Insulin secretion, Change in mean residual insulin secretion in the ITT-population measured by Mixed Meal Tolerance Test (MMTT) stimulated C-peptide two-hour area under the curve profile from visit 1 to 36 months after initiation of study treatment., 36 months|Stimulated c-peptide, Proportion of patients with peak residual insulin secretion measured by MMTT: stimulated C-peptide \>0.2 pmol/L, 36 months|C-peptide filter paper, Fasting and meal stimulated C-peptide from blood sampled on filter paper at home at 4 weekly intervals throughout the study period, 36 months|Insulin dose, Mean Insulin dosage per kilo bodyweight per 24 hours, 36 months|HbA1c, HbA1c at every control, 36 months|Hypoglycemic events, Number of severe hypoglycaemic events and less severe events requiring assistance from others with blood glucose values ≤ 3.9 mmol/L will be registered at each control, 36 months|Insulin-dose-adjusted HbA1c (IDAA1c), HbA1c adjusted to insulin dose, 36 months|Proinsulin/c-peptide ratio in serum, Proinsulin/c-peptide ratio in serum as a measure of beta cell stress, 36 months|Presence of enterovirus, Presence of enterovirus and rhinovirus and/or neutralizing antibodies against those viruses in nose, blood, saliva and stool, 36 months
Sponsor/Collaborators: Sponsor: Oslo University Hospital
Gender: ALL
Age: CHILD
Phases: PHASE2
Enrollment: 96
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-08-30
Completion Date: 2020-10-25
Results First Posted:
Last Update Posted: 2021-04-08
Locations: Pediatric department, Oslo University Hospital, Oslo, 0514, Norway
URL: https://clinicaltrials.gov/show/NCT04838145