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Clinical Trial Details

Trial ID: L3689
Source ID: NCT03272269
Associated Drug: Imcy-0098
Title: Study of IMCY-0098 in Patients With Recent Onset Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes Mellitus
Interventions: DRUG: IMCY-0098|OTHER: Placebo
Outcome Measures: Primary: Incidence of all adverse events reported for subjects, Safety assessed through measurement and comparison of any reactions or hypersensitivity to IMCY-0098 injection vs placebo. Number of adverse events will also be compared between groups with the addition of safety monitoring blood tests, up to 24 weeks | Secondary: Assessment of residual beta cell function and markers of metabolic control, Measured by a change in stimulated C-peptide production, daily insulin usage, glycated haemoglobin levels and glucose levels and excursions from baseline and between groups, up to 24 weeks | Other: Assessment of T lymphocyte immune response to IMCY-0098, Comparison of changes in IMCY-0098 specific T lymphocyte responses longitudinally following peptide treatment and versus placebo., up to 24 weeks
Sponsor/Collaborators: Sponsor: Imcyse SA
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 41
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-08-23
Completion Date: 2019-08-30
Results First Posted:
Last Update Posted: 2019-09-06
Locations: Hôpital Erasme, Brussels, Belgium|UZ Brussel, Brussels, Belgium|UZ Gent, Gent, Belgium|Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark|CHU de Nantes, Hôpital Laennec, Nantes, France|GWT-TUD GmbH, Dresden, Germany|Klaipeda University Hospital, Klaipėda, Lithuania|University Hospital Santaros Klinikos, Vilnius, Lithuania|Clinical Trial Center, CTC, Göteborg, Sweden|ProbarE Stockholm, Stockholm, Sweden|Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom|Cardiff University, Cardiff, United Kingdom|Royal Devon and Exeter NHS Trust, Exeter, United Kingdom|Guy's and St. Thomas NHS Trust, London, United Kingdom|St. Bartholomew's Hospital (Barts Health NHS Trust), London, United Kingdom|Newcastle University, Newcastle upon Tyne, United Kingdom|Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03272269

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress