Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration (MIP310)

Medtronic

Status and phase: Completed; Phase 3

Conditions: Type 1 Diabetes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00211536

CE-025A6

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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 months prior to enrollment
• Subject has a reliable support person (defined as a person who has daily contact with the subject and knows whom to contact in the event of an emergency).
• Capability and willingness to perform self-monitoring of blood glucose at least four times daily for 9 months of the study and 7 times daily for 3 months of the study
• Physical and intellectual ability to operate the MIP system and to comply with the data reporting requirements of the study.
• Subject is willing to sign the informed consent form (approved by local Institutional Review Board and Medtronic MiniMed)

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

MiniMed Implantable insulin Pump (MIP)

Experimental group

Description:

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.

Treatment:

Device: Medtronic MiniMed Implantable Pump System

Drug: Aventis HOE21PH U400

Drug: Medtronic MiniMed Implantable Pump Human Recombinant Insulin

Subcutaneous insulin arm (SC)

No Intervention group

Description:

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.