Clinical trial NCT01194882: Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-09-03
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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

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.

Primary outcomes:
measure: Refill accuracy between the 2 insulin groups
timeFrame: During 4 refill cycles
measure: Change in glycosylated hemoglobin (HbA1c)
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia
timeFrame: From baseline to 6 months
measure: Occurrence of hyperglycaemia
timeFrame: From baseline to 6 months
measure: Occurrence of diabetic ketoacidosis
timeFrame: From baseline to 6 months
measure: Change in insulin dose
timeFrame: From baseline to 6 months
measure: Antibody assessments (anti-Insulin antibodies)
timeFrame: From baseline to 6 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Investigational Site Number 056-001
city: Corbeil Essonnes
country: France
facility: Investigational Site Number 250-004
city: Dijon
country: France
facility: Investigational Site Number 250-008
city: Dommartin Les Toul
country: France
facility: Investigational Site Number 250-003
city: Le Mans Cedex 9
country: France
facility: Investigational Site Number 250-012
city: LILLE Cedex
country: France
facility: Investigational Site Number 250-009
city: Marseille
country: France
facility: Investigational Site Number 250-007
city: MONTPELLIER Cedex 5
country: France
facility: Investigational Site Number 250-001
city: Paris
country: France
facility: Investigational Site Number 250-005
city: Pessac Cedex
country: France
facility: Investigational Site Number 250-010
city: ST PRIEST EN JAREZ Cedex
country: France
facility: Investigational Site Number 250-011
city: Strasbourg
country: France
facility: Investigational Site Number 250-002
city: TOULOUSE Cedex 9
country: France
facility: Investigational Site Number 250-006
city: Den Haag
country: Netherlands
facility: Investigational Site Number 528003
city: Roermond
country: Netherlands
facility: Investigational Site Number 528002
city: Zwolle
country: Netherlands
facility: Investigational Site Number 528001
city: Stockholm
country: Sweden
facility: Investigational Site Number 752-001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Schaepelynck P, Riveline JP, Renard E, Hanaire H, Guerci B, Baillot-Rudoni S, Sola-Gazagnes A, Catargi B, Fontaine P, Millot L, Martin JF, Tachouaft H, Jeandidier N; EVADIAC Group. Assessment of a new insulin preparation for implanted pumps used in the treatment of type 1 diabetes. Diabetes Technol Ther. 2014 Sep;16(9):582-9. doi: 10.1089/dia.2013.0369. Epub 2014 Apr 15.