Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481117
Status:
COMPLETED
Last Update Posted:
2010-09-13
First Post:
2007-05-31
Brief Title:
Safety Tolerability and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Safety Tolerability PK and PD of LY2405319 After Multiple Subcutaneous Injections in Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2010-09
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 study intends to evaluate how safe and well tolerated the LY2405319 compound is when given to people for 7 days in Part 1 and 28 days in Part 2 This study intends to also determine if there is a positive effect on lowering the level of glucose in people with type 2 diabetes
Detailed Description:
Subjects in Part 1 will be randomized to receive LY2405319 or placebo over 7 days in one of 4 dose level groups in ascending order 1 mg 3 mg 10 mg or 20 mg
Subjects in Part 2 will be randomized to receive LY2405319 or placebo over 28 days and will receive the dose level determined to be the most well tolerated in Part 1
Subjects in Part 2 will be randomized to receive LY2405319 or placebo over 28 days and will receive the dose level determined to be the most well tolerated in Part 1
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 |
|---|---|---|---|
| I1K-MC-GLUD | OTHER | Eli Lilly and Company | None |