Ignite Creation Date:
2024-05-05 @ 10:50 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01194882
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2010-09-02
Brief Title:
BenefitRisk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Evaluation of Insuman Implantable 400 IUml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IUml
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To compare Insuman Implantable 400 IUml versus Insuplant 400 IUml with respect to the pump refill accuracy during a 4 refill cycle period ie the comparative phase To assess efficacy measured by hemoglobin glycosylated HBA1c change in Insuman Implantable 400 IUml group versus Insuplant 400 IUml group after a 4 refill cycle period ie 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
To compare Insuman Implantable 400 IUml versus Insuplant 400 IUml with respect to the pump refill accuracy during a 4 refill cycle period ie the comparative phase To assess efficacy measured by hemoglobin glycosylated HBA1c change in Insuman Implantable 400 IUml group versus Insuplant 400 IUml group after a 4 refill cycle period ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1116-7658 | OTHER | UTN | None |
| 2010-021373-37 | EUDRACT_NUMBER | None | None |