Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-25 @ 4:11 PM
Study NCT ID:
NCT01456195
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2011-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 mg and 50 mg Compared With Placebo in Subjects With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-03
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 purpose of this study is to determine the efficacy and safety of TAK-875 (fasiglifam), once daily (QD), in participants with type 2 diabetes mellitus (T2DM).
Detailed Description:
TAK-875 is being developed at Takeda Development Center, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.
This study will investigate TAK-875 in participants with type 2 diabetes mellitus who have been treated with only diet and exercise for at least 12 weeks prior to Screening, who have taken ≤7 days of any antidiabetic agent within the 12 weeks prior to Screening, and whose glycemic control is inadequate.
This study will investigate TAK-875 in participants with type 2 diabetes mellitus who have been treated with only diet and exercise for at least 12 weeks prior to Screening, who have taken ≤7 days of any antidiabetic agent within the 12 weeks prior to Screening, and whose glycemic control is inadequate.
Study Oversight
Has Oversight DMC:
True
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?: