Diabetes Mellitus, Type 1
Conditions
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
Interventions
DRUGHUMAN INSULIN (BIOSYNTHETIC)
Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
DRUGInsuplant
Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen:
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refill accuracy between the 2 insulin groups | During 4 refill cycles |
| Change in glycosylated hemoglobin (HbA1c) | From baseline to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of diabetic ketoacidosis | From baseline to 6 months |
| Occurrence of Hypoglycaemia (asymptomatic and symptomatic hypoglycaemia, severe and serious symptomatic hypoglycaemia | From baseline to 6 months |
| Antibody assessments (anti-Insulin antibodies) | From baseline to 6 months |
| Change in insulin dose | From baseline to 6 months |
| Occurrence of hyperglycaemia | From baseline to 6 months |
Countries
Belgium, France, Netherlands, Sweden
Outcome results
None listed