Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 8:03 AM
Study NCT ID:
NCT02293551
Status:
COMPLETED
Last Update Posted:
2025-09-08
First Post:
2014-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Lispro Formulations in Healthy Participants
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations
Status:
COMPLETED
Status Verified Date:
2025-09
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:
The purposes of this study are to determine:
* Part A
* How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
* The safety of insulin lispro in different formulations and any side effects that might be associated with it.
* Part B:
* How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).
* The safety of insulin lispro in different formulations and any side effects that might be associated with it.
Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.
* Part A
* How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
* The safety of insulin lispro in different formulations and any side effects that might be associated with it.
* Part B:
* How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).
* The safety of insulin lispro in different formulations and any side effects that might be associated with it.
Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| F3Z-FW-ITCA | OTHER | Eli Lilly and Company | View |