Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-27 @ 11:03 AM
Study NCT ID:
NCT00101751
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2005-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study
Sponsor:
Novo Nordisk A/S
Organization:
Study Overview
Official Title:
Efficacy and Safety of a Standard Titration Algorithm Coupled With a Conventional Dietary Intervention or Intensive Dietary Intervention Versus a Standard Titration Algorithm, Alone, in Patients With Type 2 Diabetes Initiating NovoLog® Mix 70/30 Therapy
Status:
COMPLETED
Status Verified Date:
2023-10
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:
INITIATE plus
Brief Summary:
This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.
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?: