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Clinical Trial Details

Trial ID: L2124
Source ID: NCT01194882
Associated Drug: Human Insulin (Biosynthetic)
Title: Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 1
Interventions: DRUG: HUMAN INSULIN (BIOSYNTHETIC)|DRUG: Insuplant
Outcome Measures: Primary: Refill accuracy between the 2 insulin groups, During 4 refill cycles|Change in glycosylated hemoglobin (HbA1c), From baseline to 6 months | Secondary: Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia, From baseline to 6 months|Occurrence of hyperglycaemia, From baseline to 6 months|Occurrence of diabetic ketoacidosis, From baseline to 6 months|Change in insulin dose, From baseline to 6 months|Antibody assessments (anti-Insulin antibodies), From baseline to 6 months
Sponsor/Collaborators: Sponsor: Sanofi
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 479
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2010-11-16
Completion Date: 2018-02-01
Results First Posted:
Last Update Posted: 2018-02-15
Locations: Investigational Site Number 056-001, Leuven, 3000, Belgium|Investigational Site Number 250-004, Corbeil Essonnes, 91100, France|Investigational Site Number 250-008, Dijon, 21000, France|Investigational Site Number 250-003, Dommartin Les Toul, 54200, France|Investigational Site Number 250-012, Le Mans Cedex 9, 72037, France|Investigational Site Number 250-009, LILLE Cedex, 59037, France|Investigational Site Number 250-007, Marseille, 13385, France|Investigational Site Number 250-001, MONTPELLIER Cedex 5, 34295, France|Investigational Site Number 250-005, Paris, 75014, France|Investigational Site Number 250-010, Pessac Cedex, 33604, France|Investigational Site Number 250-011, ST PRIEST EN JAREZ Cedex, 42277, France|Investigational Site Number 250-002, Strasbourg, 67091, France|Investigational Site Number 250-006, TOULOUSE Cedex 9, 31059, France|Investigational Site Number 528003, Den Haag, 2512VA, Netherlands|Investigational Site Number 528002, Roermond, 6043CV, Netherlands|Investigational Site Number 528001, Zwolle, 8025AB, Netherlands|Investigational Site Number 752-001, Stockholm, Sweden
URL: https://clinicaltrials.gov/show/NCT01194882