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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: HUMAN INSULIN (BIOSYNTHETIC); Drug: Insuplant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01194882

HUBIN_L_05335

2010-021373-37 (EudraCT Number)

U1111-1116-7658 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 479 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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479 participants in 2 patient groups

Insuman Implantable

Experimental group

Description:

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.

Treatment:

Drug: HUMAN INSULIN (BIOSYNTHETIC)

Insuplant

Active Comparator group

Description:

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.

Treatment:

Drug: Insuplant