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Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes

NCT01194882

CompletedPhase 3

Sponsor: Sanofi

Conditions: Diabetes Mellitus, Type 1

Interventions: HUMAN INSULIN (BIOSYNTHETIC), Insuplant

Countries: Belgium, France, Netherlands, Sweden

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

1. Patients already treated with Insuplant 400 IU/ml via a Medtronic Implantable System 2007
2. Glycosylated hemoglobin ≤9.0%
3. Patient showing a percentage of error at refill equal or below 20%
4. 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)
5. Signed informed consent form prior to enrolment

Exclusion criteria:

1. Pump life time \> 6 years
2. Pump battery voltage \< 2.6 volts
3. 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.
Locations (17)
  • Leuven, Belgium
  • Corbeil-Essonnes, France
  • Dijon, France
  • Dommartin-lès-Toul, France
  • Le Mans, France
  • Lille, France
  • Marseille, France
  • Montpellier, France
  • Paris, France
  • Pessac, France
  • Saint-Priest-en-Jarez, France
  • Strasbourg, France
  • Toulouse, France
  • Roermond, Netherlands
  • The Hague, Netherlands
  • Zwolle, Netherlands
  • Stockholm, Sweden