Ignite Creation Date:
2025-12-17 @ 2:50 PM
Ignite Modification Date:
2025-12-23 @ 4:53 PM
Study NCT ID:
NCT01029795
Status:
TERMINATED
Last Update Posted:
2011-12-02
First Post:
2009-12-09
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2599506 Given as Monotherapy or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus
Status:
TERMINATED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to nonclinical safety findings
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to help answer the following research question(s):
* To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks.
* To evaluate the safety of LY2599506 in participants with diabetes.
* To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
* To determine how much LY2599506 should be given to participants.
* To determine if LY2599506 has an effect on a participant's weight.
The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow up period.
* To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks.
* To evaluate the safety of LY2599506 in participants with diabetes.
* To determine if LY2599506 has the ability to control blood sugar in participants with diabetes.
* To determine how much LY2599506 should be given to participants.
* To determine if LY2599506 has an effect on a participant's weight.
The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow up period.
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 |
|---|---|---|---|---|
| I2Q-MC-GMAJ | OTHER | Eli Lilly and Company | View |