Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453934
Status:
TERMINATED
Last Update Posted:
2007-12-06
First Post:
2007-03-27
Brief Title:
Patient Preference of h-Patch vs Pen or NeedleSyringe as Insulin Administration Device
Sponsor:
Valeritas Inc
Organization:
Valeritas Inc
Study Overview
Official Title:
h-Patch vs Pen or Needle and Syringe as Insulin Administration Device in Type 1 or 2 Diabetes Patients Using MDI Patient Preference and Glycemic Control After Switch in an Open-Label Randomized Cross-Over Study
Status:
TERMINATED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Endpoint no longer deemed meaningful
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare patient preference of the h-Patch as delivery device for insulin lispro compared with either an insulin pen or needle and syringe in patients with diabetes either Type 1 or Type 2 on stable multiple daily injection regimens This will be assessed using an accepted preference scale
Detailed Description:
Patients with Type 1 Diabetes have an absolute deficiency in insulin production and benefit from physiologic insulin replacement defined as administration of background and mealtime insulin More than half of patients with Type 2 diabetes T2DM have less than 50 of their beta cell function at the time of diagnosis Because of this these patients would also benefit from the physiologic delivery of insulin Currently 4 or more injections per day are required to deliver the various different available insulins in a physiologic manner Valeritas has developed the h-Patch a device suitable to make the delivery of basal and bolus insulin effective simple and discrete This study will measure patient preference glucose control and safety of the h-Patch compared with patients previous therapy Patients previous therapy will be multiple daily injections delivered either by pens or needle and syringe
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