A Randomized, Active Control, Multi-Center Study Comparing the Effect of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration on Glycemic Control and the Frequency of Severe Hypoglycemia
Overview
- Phase
- Phase 3
- Intervention
- Medtronic MiniMed Implantable Pump Human Recombinant Insulin
- Conditions
- Type 1 Diabetes
- Sponsor
- Medtronic Diabetes
- Enrollment
- 107
- Locations
- 5
- Primary Endpoint
- Change in HbA1c and Compared Between Groups
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.
Detailed Description
Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •The subject's insulin usage exceeds 66 units per day.
- •Severe complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months
- •Reside at or plan to travel to elevations above 8000 feet during the study period (commercial airline travel is acceptable)
- •Subject who is pregnant, of childbearing potential or lactating and is neither surgically sterile, using contraceptives (devices, oral or implanted) nor other physician approved contraceptive
- •The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data
- •The subject has previously enrolled in or participated in an investigational drug or device study within the preceding 4 weeks
- •The subject has any condition that precludes him/her from completing the study requirements
- •Has plans for activities which require them to go 25 feet below sea level
Arms & Interventions
MiniMed Implantable insulin Pump (MIP)
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.
Intervention: Medtronic MiniMed Implantable Pump Human Recombinant Insulin
MiniMed Implantable insulin Pump (MIP)
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.
Intervention: Medtronic MiniMed Implantable Pump System
MiniMed Implantable insulin Pump (MIP)
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.
Intervention: Aventis HOE21PH U400
Outcomes
Primary Outcomes
Change in HbA1c and Compared Between Groups
Time Frame: Baseline and 12 months
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.
Incidence of Severe Hypoglycemia Events
Time Frame: 12 months
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.
Secondary Outcomes
- Average Daily Blood Glucose(average from baseline to 12 months)
- Mean Amplitude of Glycemic Excursions (MAGE)(average from baseline to 12 months)
- Low Blood Glucose Index (LBGI);(average from baseline to 12 months)