Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-03 @ 9:34 PM
Study NCT ID:
NCT01868568
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2013-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 Diabetes
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
A Randomised, Double-blind, Multiple Period Cross-over Trial Comparing Insulin 454 and Insulin Aspart Fixed Combination Products With Separately Injected, Simultaneous Doses of Insulin 454 and Insulin Aspart, Compared to Biphasic Insulin Aspart 30 (NovoMix® 30) in Subjects With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2015-10
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 trial is conducted in Europe. The aim of this trial is to compare insulin degludec and insulin aspart (IDegAsp) co-formulations with separately injected, simultaneous doses of insulin degludec (insulin 454) and insulin aspart, compared with biphasic insulin aspart 30 (NovoMix® 30) in subjects with type 1 diabetes mellitus. Each subject will be randomised to four out of nine possible treatment arms. IDegAsp 40, IDegAsp 45, IDegAsp 55 and IDeg high concentration were explorative formulations, not similar to the proposed commercial formulation.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-006110-42 | EUDRACT_NUMBER | None | View |