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

• Refill accuracy between the 2 insulin groups [ Time Frame: During 4 refill cycles ] [ Designated as safety issue: No ]
• Change in glycosylated hemoglobin (HbA1c) [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]

• Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
• Occurrence of hyperglycaemia [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
• Occurrence of diabetic ketoacidosis [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
• Change in insulin dose [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]
• Antibody assessments (anti-Insulin antibodies) [ Time Frame: From baseline to 6 months ] [ Designated as safety issue: No ]

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

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

• Drug: HUMAN INSULIN (BIOSYNTHETIC)
  Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
  Other Name: HR1799
• Drug: Insuplant

  Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use

  Dose regimen:

  Other Name: Human insulin semi synthetic porcine derived

• Experimental: Insuman Implantable
  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.
  Intervention: Drug: HUMAN INSULIN (BIOSYNTHETIC)
• Active Comparator: 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.
  Intervention: Drug: Insuplant

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.