Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Drug: HUMAN INSULIN (BIOSYNTHETIC)Drug: Insuplant
- Registration Number
- NCT01194882
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative phase).
Secondary Objective:
To assess efficacy, safety, refill accuracy evolution and device interventions during the open-label treatment period with Insuman To evaluate daily insulin doses To assess Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases
- Detailed Description
The study duration will be displayed in 2 parts as follow:
Comparative phase (only French patients): 160 +/- 20 days Open label Insuman Implantable extension phase (French and European patients): from day 160 up to the grant of Insuman implantable marketing authorization
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 479
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insuman Implantable HUMAN INSULIN (BIOSYNTHETIC) Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines. Insuplant Insuplant Starting dose regimen is the same as the one administered to the patient prior randomization, then the insulin odse is established by the investigator on a patient basis in respect to the American Diabetes Association guidelines.
- Primary Outcome Measures
Name Time Method Change in glycosylated hemoglobin (HbA1c) From baseline to 6 months Refill accuracy between the 2 insulin groups During 4 refill cycles
- Secondary Outcome Measures
Name Time Method Antibody assessments (anti-Insulin antibodies) From baseline to 6 months 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 Change in insulin dose From baseline to 6 months Occurrence of diabetic ketoacidosis From baseline to 6 months
Trial Locations
- Locations (17)
Investigational Site Number 250-005
🇫🇷Paris, France
Investigational Site Number 250-004
🇫🇷Corbeil Essonnes, France
Investigational Site Number 752-001
🇸🇪Stockholm, Sweden
Investigational Site Number 528003
🇳🇱Den Haag, Netherlands
Investigational Site Number 056-001
🇧🇪Leuven, Belgium
Investigational Site Number 250-011
🇫🇷ST PRIEST EN JAREZ Cedex, France
Investigational Site Number 250-008
🇫🇷Dijon, France
Investigational Site Number 250-010
🇫🇷Pessac Cedex, France
Investigational Site Number 250-012
🇫🇷Le Mans Cedex 9, France
Investigational Site Number 250-009
🇫🇷LILLE Cedex, France
Investigational Site Number 250-007
🇫🇷Marseille, France
Investigational Site Number 250-002
🇫🇷Strasbourg, France
Investigational Site Number 250-006
🇫🇷TOULOUSE Cedex 9, France
Investigational Site Number 250-003
🇫🇷Dommartin Les Toul, France
Investigational Site Number 250-001
🇫🇷MONTPELLIER Cedex 5, France
Investigational Site Number 528002
🇳🇱Roermond, Netherlands
Investigational Site Number 528001
🇳🇱Zwolle, Netherlands