Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366379
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-08-16
Brief Title:
A Dose-Titration Study of GK Activator 2 in Patients With Type 2 Diabetes
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open Label Study to Determine the Effect on Fasting Glucose Levels and Safety of Increasing Doses of GK Activator 2 in Patients With Type 2 Diabetes Not Optimally Controlled With One Previous Oral Antihyperglycemic Agent
Status:
COMPLETED
Status Verified Date:
2016-11
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 will assess the efficacy safety and tolerability of increasing doses of GK Activator 2 in patients with type 2 diabetes whose condition has not been optimally controlled with one previous oral antihyperglycemic agent After a 2 week washout from their previous antidiabetic therapy patients will receive GK Activator 2 orally twice a day for 12 weeks at increasing doses of 25mg bid to 200mg bid doses will be titrated to achieve a target fasting glucose level FPG of 100mgdL The anticipated time on study treatment is 3 months and the target sample size is 100-500 individuals
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