Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aventis HOE21PH U400 · 1 trial · 1 indication
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...
Aventis HOE21PH U400 is an investigational small molecule being developed for the treatment of Type 1 Diabetes. It is currently in Phase 3 clinical development. The drug is being studied for its potential to manage blood glucose levels in patients with this condition.
Aventis HOE21PH U400 is being developed by MiniMed Group, Inc., a company traded under the ticker symbol MMED. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes.
Aventis HOE21PH U400 is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed to assess its effectiveness in treating Type 1 Diabetes.
Aventis HOE21PH U400 has one completed Phase 3 clinical trial, identified as NCT00211536. This study compared the effectiveness of intraperitoneal insulin administration to subcutaneous insulin administration in 107 patients with Type 1 Diabetes. The trial was conducted in the United States.
Aventis HOE21PH U400 is an investigational drug being studied for Type 1 Diabetes. The completed clinical trial compared intraperitoneal insulin administration to subcutaneous insulin administration, indicating that the drug may be a form of insulin or an insulin-related therapy. However, the exact composition is not specified.