Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191464
Status:
COMPLETED
Last Update Posted:
2010-10-13
First Post:
2005-09-12
Brief Title:
Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes A Comparison of Premeal Insulin Lispro Mixtures to Once-Daily Insulin Glargine
Status:
COMPLETED
Status Verified Date:
2010-10
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:
The primary objective of this study is to show that a prandial insulin regimen consisting of premeal insulin lispro mid mixture or a combined regimen of insulin lispro mid mixture and insulin lispro low mixture plus metformin will result in significantly better overall glycemic control lower HbA1c at endpoint than once-daily insulin glargine plus metformin Insulin lispro mid mixture consists of 50 insulin lispro and 50 NPL Insulin lispro low mixture consists of 25 insulin lispro and 75 NPL
In a substudy of approximately 60 patients additional data will be collected on markers associated with risk of atherosclerosis or cardiovascular disease in the context of a controlled outpatient high-fat test meal
In a substudy of approximately 60 patients additional data will be collected on markers associated with risk of atherosclerosis or cardiovascular disease in the context of a controlled outpatient high-fat test meal
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 |
|---|---|---|---|
| F3Z-MC-IOOI | None | None | None |