Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-11 @ 6:59 AM
Study NCT ID:
NCT01414920
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2011-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of TAK-875 in Combination With Sitagliptin in Participants With Type 2 Diabetes Mellitus
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Placebo-Controlled, Factorial, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of 25 mg and 50 mg of TAK-875 in Combination With Sitagliptin 100 mg in Subjects With Type 2 Diabetes Mellitus
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, once daily (QD), in combination with sitagliptin QD in participants with type 2 diabetes mellitus (T2DM).
Detailed Description:
TAK-875 is being developed at Takeda Global Research and Development, Inc. as an adjunct to diet and exercise to improve glycemic control in patients with T2DM.
Sitagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.
This study will investigate the effects of the combination of TAK-875 with a DDP-4 inhibitor on glycosylated hemoglobin reduction.
Sitagliptin is an inhibitor of dipeptidyl peptidase-4 (DPP-4) approved as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.
This study will investigate the effects of the combination of TAK-875 with a DDP-4 inhibitor on glycosylated hemoglobin reduction.
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 |
|---|---|---|---|---|
| U1111-1115-5044 | REGISTRY | WHO | View |