Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2025-12-26 @ 5:28 PM
Study NCT ID:
NCT01074268
Status:
COMPLETED
Last Update Posted:
2017-03-06
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of NN1250 Plus Insulin Aspart With Insulin Detemir Plus Insulin Aspart in Type 1 Diabetes
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
NN1250-3585: A Trial Investigating the Efficacy and Safety of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen / NN1250-3725: An Extension Trial to NN1250-3585 Investigating Safety and Efficacy of NN1250 Compared to Insulin Detemir in Subjects With Type 1 Diabetes Mellitus in a Basal/Bolus Treatment Regimen (BEGIN™: BB T1)
Status:
COMPLETED
Status Verified Date:
2017-01
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:
BEGIN™
Brief Summary:
This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart.
The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.
The main period is registered internally at Novo Nordisk as NN1250-3585 while the extension period is registered as NN1250-3725.
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?: