Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036192
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2002-05-08
Brief Title:
Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic subjects receiving sulfonylurea SU monotherapy
Detailed Description:
This is a prospective randomized double-blind placebo controlled parallel group Phase 2 study Subjects meeting selection criteria will be randomly assigned to receive 12 weeks twice daily BID dosing with FK614 or placebo Enrollment for this study will be approximately 200 patients
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