Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

NCT ID: NCT00211536

Last Updated: 2011-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2008-09-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Medtronic MiniMed Implantable Pump Human Recombinant Insulin

Intervention Type: DRUG

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Medtronic MiniMed Implantable Pump System

Intervention Type: DEVICE

The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.

Aventis HOE21PH U400

Intervention Type: DRUG

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Subcutaneous insulin arm (SC)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Medtronic MiniMed Implantable Pump Human Recombinant Insulin

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Intervention Type: DRUG

Medtronic MiniMed Implantable Pump System

The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.

Intervention Type: DEVICE

Aventis HOE21PH U400

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Intervention Type: DRUG

Other Intervention Names

Human insulin injection (rDNA origin); IP insulin pump system; Aventis U400 insulin; Aventis ETP Insulin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott W Lee, MD

Role: STUDY_DIRECTOR

Medtronic

Locations

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

Countries

United States

Other Identifiers

CE-025A6

Identifier Type: -

Identifier Source: org_study_id