Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391209
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2006-10-19
Brief Title:
Compare Two Dosing Algorithms in Insulin-Naive Patients With Type 2 Diabetes Mellitus
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase 3 Open-Label Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder HIIP in Insulin-Naive Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2018-03
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 randomized multicenter open-label active-comparator 2-arm parallel-group 6 month study with approximately 360 patients will compare the efficacy of two treatment regimens Algorithm A versus Algorithm B in insulin-naive patients with type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications Patients will be assigned randomly to receive one of the following treatment groups
Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP also known as AIR Inhaled InsulinAIR is a registered trademark of AlkermesInc titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study increasing total daily dose by a maximum of 6 U per day
Algorithm B is defined as an intensive diabetes management regimen starting with an adjusted dose of AIR Inhaled Insulin titrating 2 times per week based on daily 4 point blood glucose values with sustained monitoring of dose and blood glucose throughout the study increasing total daily dose by a maximum of 8 U per day
Algorithm A is defined as a simplified diabetes management regimen starting with a fixed dose of HIIP also known as AIR Inhaled InsulinAIR is a registered trademark of AlkermesInc titrating 2 times per week based on 2 times per week 4 point blood glucose values for the first month and titrating 1 time per week based on once weekly 4-point blood glucose values for the remainder of the study increasing total daily dose by a maximum of 6 U per day
Algorithm B is defined as an intensive diabetes management regimen starting with an adjusted dose of AIR Inhaled Insulin titrating 2 times per week based on daily 4 point blood glucose values with sustained monitoring of dose and blood glucose throughout the study increasing total daily dose by a maximum of 8 U per day
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H7U-MC-IDAY | OTHER | Eli Lilly and Company | None |