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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00211536 | Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration | PHASE3 | COMPLETED | 107 | — | — | Jun 1, 2002 | Sep 1, 2008 | Sep 21, 2011 | 5 | United States |
To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts.
The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months.
| Arm | Type | Description |
|---|---|---|
| MiniMed Implantable insulin Pump (MIP) | EXPERIMENTAL | The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin. |
| Subcutaneous insulin arm (SC) | NO_INTERVENTION | The control group will remain on their current pre-study subcutaneous insulin therapy of either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used, or be required to change or modify their current diabetes therapy for the purpose of the study. |
| Name | Type | Description |
|---|---|---|
| Medtronic MiniMed Implantable Pump Human Recombinant Insulin | DRUG | 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. |
| Medtronic MiniMed Implantable Pump System | DEVICE | The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes. |
| Aventis HOE21PH U400 | DRUG | 400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. |
* Type 1 diabetes mellitus (American Diabetes Association definition) * HbA1c greater than or equal to 7.5% * Intensive insulin treatment for at least 3 months * Physical and intellectual ability to operate MIP system * Subject has been under the routine care of the investigator for at least two mon...