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Clinical Trial Details

Trial ID: L5219
Source ID: NCT02387164
Associated Drug: Alum-Gad
Title: Prevention Trial: Immune-tolerance With Alum-GAD (Diamyd) and Vitamin D3 to Children With Multiple Islet Autoantibodies
Acronym: DiAPREV-IT2
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02387164/results
Conditions: Diabetes Mellitus, Type 1|Prediabetic State
Interventions: DRUG: Alum-GAD|DRUG: Vitamin D3
Outcome Measures: Primary: Type 1 Diabetes Month 24, Number of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm month 24, 24 months|Type 1 Diabetes Status Overall, Number of patients diagnosed with type 1 diabetes according to ADA (American Diabetes Association) criteria in each study arm overall. Including one patient diagnosed shortly after the month 24 visit., Over the entire study period up to 2 years | Secondary: Number of Patients Developing Impaired Glucose Metabolism Until Month 18, Change in metabolic status from normal to impaired glucose metabolism during follow-up in the group of children with normal glucose metabolism at baseline screening. Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more., During 18 months follow-up|Number of Patients With Progressive Impaired Glucose Metabolism Until Month 18, Number of patients who have progression from already impaired glucose metabolism from one or several criteria to additional signs of reduced glucose metabolism (within children with impaired glucose metabolism at screening). Impaired glucose metabolism is defined as a) fasting plasma glucose 6.1 mmol/L or more, b) maximum plasma glucose 30, 60, 90 min during oral glucose tolerance test (OGTT) 11.1 mmol/L or more, c) 120 min plasma glucose on OGTT 7.8 mmol/L or more, d) HbA1c 39 mmol/L or more., During 18 months follow-up|Injection Site Reactions Day 1, Number of patients experiencing injection site reactions at day 1, Day 1|Injection Site Reactions Month 1, Number of patients experiencing injection site reactions at month 1, Month 1|Change From Baseline in GADA Month 1, Change from baseline to month 1 in GADA (Glutamic Acid Decarboxylase Antibodies) titers, Month 1|Change From Baseline in GADA Month 12, Change from baseline to month 12 in GADA titers, Month 12|Change From Baseline in GADA Month 24, Change from baseline to month 24 in GADA titers, Month 24
Sponsor/Collaborators: Sponsor: Lund University | Collaborators: Region Skane
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 26
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2015-03-09
Completion Date: 2019-10-07
Results First Posted: 2020-10-27
Last Update Posted: 2020-11-17
Locations: Clinical Research Center, Pediatric Endocrinology, Jan Waldenströms gata 35, 60:11, Malmö, 205 02, Sweden
URL: https://clinicaltrials.gov/show/NCT02387164