Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286962
Status:
COMPLETED
Last Update Posted:
2008-04-11
First Post:
2006-02-03
Brief Title:
Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
Sponsor:
Medical Research Foundation The Netherlands
Organization:
Medical Research Foundation The Netherlands
Study Overview
Official Title:
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
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 040211p | None | None | None |