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Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

NCT00211536 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2011-09-21

Study results available
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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.

Conditions

Interventions

DRUG

Medtronic MiniMed Implantable Pump Human Recombinant Insulin

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

DEVICE

Medtronic MiniMed Implantable Pump System

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

DRUG

Aventis HOE21PH U400

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

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Scott W Lee, MD · Medtronic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2004-08-31
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00211536 on ClinicalTrials.gov