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

Study Overview
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Brief Summary
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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
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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

Official Title
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Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: HUMAN INSULIN (BIOSYNTHETIC)
* Drug: Insuplant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insuman Implantable<br>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. | Drug: HUMAN INSULIN (BIOSYNTHETIC)<br>* Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml<br>* Other names: HR1799;|
| Active Comparator: Insuplant<br>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. | Drug: Insuplant<br>* Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen:<br>* Other names: Human insulin semi synthetic porcine derived;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refill accuracy between the 2 insulin groups |  | During 4 refill cycles | 
| Change in glycosylated hemoglobin (HbA1c) |  | From baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |