Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01194882 | Benefit/Risk Evaluation of Insuman Implantable Versus Insuplant Using Medtronic MiniMed Implantable Pump System in Patients With Type 1 Diabetes | PHASE3 | COMPLETED | 479 | — | — | Nov 16, 2010 | Feb 1, 2018 | Feb 15, 2018 | 17 | Belgium, France +2 |
| Arm | Type | Description |
|---|---|---|
| Insuman Implantable | EXPERIMENTAL | 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. |
| Insuplant | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| HUMAN INSULIN (BIOSYNTHETIC) | DRUG | Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml |
| Insuplant | DRUG | Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use Dose regimen: |
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 wi...