Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

Phase 3

Completed

Conditions: Type 1 Diabetes

Interventions: Drug: Medtronic MiniMed Implantable Pump Human Recombinant Insulin
Device: Medtronic MiniMed Implantable Pump System
Drug: Aventis HOE21PH U400

Registration Number: NCT00211536

Lead Sponsor: Medtronic Diabetes

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 107

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MiniMed Implantable insulin Pump (MIP)	Medtronic MiniMed Implantable Pump Human Recombinant Insulin	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.
MiniMed Implantable insulin Pump (MIP)	Medtronic MiniMed Implantable Pump System	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.
MiniMed Implantable insulin Pump (MIP)	Aventis HOE21PH U400	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.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c and Compared Between Groups	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	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 Outcome Measures

Name	Time	Method
Average Daily Blood Glucose	average from baseline to 12 months	For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.
Mean Amplitude of Glycemic Excursions (MAGE)	average from baseline to 12 months	MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.
Low Blood Glucose Index (LBGI);	average from baseline to 12 months	4 to 10 daily blood glucose readings (BG) were required for this measure. LBGI was calculated from BG values collected for 30 days prior to Visit 2 and 30 days following Visits 5 and 7. The continuous measure was compared between the two treatment groups for the three periods with a repeated measures ANOVA using proc mixed. Type 3 least square means for each group were assessed and estimate statements used to make comparisons among the LS means and create confidence intervals on the contrasts.

Trial Locations

Locations (5): Sansum Medical Research Institute
🇺🇸
Santa Barbara, California, United States
University of Colorado Health Sciences Center
🇺🇸
Aurora, Colorado, United States
Hellman & Rosen Endocrine Associates
🇺🇸
North Kansas City, Missouri, United States
Cleveland Clinic
🇺🇸
Wooser, Ohio, United States
Diabetes & Glandular Disease Clinic
🇺🇸
San Antonio, Texas, United States