Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519623
Status:
COMPLETED
Last Update Posted:
2010-12-30
First Post:
2007-08-02
Brief Title:
Transdermal Basal Insulin Patch Study in Type 1 Diabetes
Sponsor:
Altea Therapeutics
Organization:
Altea Therapeutics
Study Overview
Official Title:
PharmacokineticPharmacodynamic Study of the PassPortR Transdermal Insulin Delivery System in Type 1 Diabetes Patients
Status:
COMPLETED
Status Verified Date:
2010-12
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:
This study is designed to evaluate the pharmacokineticspharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients
Detailed Description:
The study is looking for patients that meet the following criteria
Duration of type diabetes greater than or equal to 10 years
HbA1C less than or equal to 90
C-peptide negative
Ages 18 - 65 male or female
Body Mass Index BMI 185 - 32
Non-smoker
No advanced diabetes complications
Not pregnant or breast feeding
Duration of type diabetes greater than or equal to 10 years
HbA1C less than or equal to 90
C-peptide negative
Ages 18 - 65 male or female
Body Mass Index BMI 185 - 32
Non-smoker
No advanced diabetes complications
Not pregnant or breast feeding
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