Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 3:53 PM
Study NCT ID:
NCT00453934
Status:
TERMINATED
Last Update Posted:
2007-12-06
First Post:
2007-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Preference of h-Patch vs. Pen or Needle/Syringe as Insulin Administration Device
Sponsor:
Valeritas, Inc.
Organization:
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:
False
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?: