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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194882
• Other study ID #: HUBIN_L_05335
• Secondary ID: 2010-021373-37U1
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2010
• Last updated: February 14, 2018
• Start date: November 16, 2010
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056-001	Leuven
France	Investigational Site Number 250-004	Corbeil Essonnes
France	Investigational Site Number 250-008	Dijon
France	Investigational Site Number 250-003	Dommartin Les Toul
France	Investigational Site Number 250-012	Le Mans Cedex 9
France	Investigational Site Number 250-009	LILLE Cedex
France	Investigational Site Number 250-007	Marseille
France	Investigational Site Number 250-001	MONTPELLIER Cedex 5
France	Investigational Site Number 250-005	Paris
France	Investigational Site Number 250-010	Pessac Cedex
France	Investigational Site Number 250-011	ST PRIEST EN JAREZ Cedex
France	Investigational Site Number 250-002	Strasbourg
France	Investigational Site Number 250-006	TOULOUSE Cedex 9
Netherlands	Investigational Site Number 528003	Den Haag
Netherlands	Investigational Site Number 528002	Roermond
Netherlands	Investigational Site Number 528001	Zwolle
Sweden	Investigational Site Number 752-001	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Belgium,  France,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refill accuracy between the 2 insulin groups		During 4 refill cycles
Primary	Change in glycosylated hemoglobin (HbA1c)		From baseline to 6 months
Secondary	Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia		From baseline to 6 months
Secondary	Occurrence of hyperglycaemia		From baseline to 6 months
Secondary	Occurrence of diabetic ketoacidosis		From baseline to 6 months
Secondary	Change in insulin dose		From baseline to 6 months
Secondary	Antibody assessments (anti-Insulin antibodies)		From baseline to 6 months