Status:
COMPLETED
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
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): fro...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007
- Glycosylated hemoglobin ≤9.0%
- Patient showing a percentage of error at refill equal or below 20%
- Patient undergoing NaOH rinse procedure of at least 10 minutes period with or without flush Or Patient being re-implanted with a new pump (first fill with insulin)
- Signed informed consent form prior to enrolment
- Exclusion criteria:
- Pump life time \> 6 years
- Pump battery voltage \< 2.6 volts
- Pregnancy or childbearing potential without a medically approved form of birth control
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
November 16 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT01194882
Start Date
November 16 2010
End Date
February 1 2018
Last Update
February 15 2018
Active Locations (17)
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1
Investigational Site Number 056-001
Leuven, Belgium, 3000
2
Investigational Site Number 250-004
Corbeil-Essonnes, France, 91100
3
Investigational Site Number 250-008
Dijon, France, 21000
4
Investigational Site Number 250-003
Dommartin-lès-Toul, France, 54200