NCT00286962

Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

A Randomized Cross-Over Single Centre Study Comparing the Effects of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medical Research Foundation, The Netherlands · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus.

Detailed description

Various study data available suggest that intraperitoneal (IP) delivery of insulin in type 1 and type 2 diabetic subjects provides an appropriate therapy that allows subjects to achieve acceptable glycemic control without increasing the inherent risk of severe hypoglycemia observed when intensive insulin treatment is pursued. Up till now little research has been done to investigate the efficacy of intraperitoneal (IP) therapy compared to subcutaneous administration. In this study we aim for safety and non-inferiority or superiority for IP therapy concerning glycemic control with less episodes of hypoglycemia compared to intensive subcutaneous (SC) therapy in intermediate or poorly controlled Type 1 patients and/or patients with frequent severe hypoglycemic events. Subjects will be randomized to insulin treatment using the Medtronic Minimed Implantable Pump or to subcutaneous insulin therapy during the first study arm. After the first arm of the study, subjects will be crossed over to the second arm and will receive the treatment whichever they had not received in the first treatment phase. Subjects with the MIP already implanted will retain the pump but will receive diluent intraperitoneally for the second study arm.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	MIP 2007C implantable insulin pump	Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
DEVICE	continuous subcutaneous insulin infusion (CSII) or MDI

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-02-06
• Last updated: 2008-04-11

Locations

1 site across 1 country: Netherlands