NCT00211536

Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-06-01
• Primary completion: 2004-08-01
• Completion: 2008-09-01
• First posted: 2005-09-21
• Last updated: 2011-09-21
• Results posted: 2011-06-23

Locations

5 sites across 1 country: United States