Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-29 @ 2:17 PM
Study NCT ID:
NCT02206568
Status:
WITHDRAWN
Last Update Posted:
2020-07-15
First Post:
2014-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Ultra-Rapid-Acting Insulin Lispro (URAL) in Type 1 Diabetes Mellitus
Sponsor:
Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Randomised Trial Investigating Pharmacokinetic Properties of Ultra-Rapid-Acting Insulin Lispro (URAL) in Subjects With Type 1 Diabetes Mellitus
Status:
WITHDRAWN
Status Verified Date:
2015-05
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:
To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).
Detailed Description:
To compare the total pharmacodynamic response of URAL and insulin lispro.
To compare the total pharmacokinetic exposure between URAL and insulin lispro.
To assess the safety and tolerability of URAL and insulin lispro.
To compare the total pharmacokinetic exposure between URAL and insulin lispro.
To assess the safety and tolerability of URAL and insulin lispro.
Study Oversight
Has Oversight DMC:
True
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?: