Double Blind Comparative Study of TAK-875 | NCT01585792

Studies
Double Blind Comparative Study of TAK-875

NCT01585792

Sponsor

Takeda

Status

Completed

Last Update Posted

Apr 16, 2013Estimated

Enrollment

80Actual

Phase

Phase 3

Conditions

Diabetic Patients

Interventions

TAK-875
TAK-875
Glimepiride
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1129-7907	Registry Identifier	WHO
JapicCTI-121816	Registry Identifier	JapicCTI

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Apr 24, 2012

First Submission Date that Met QC Criteria

Apr 25, 2012

First Posted Date

Apr 26, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2013

Last Update Posted Date

Apr 16, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
TAK-875 25 mg	Experimental	Drug: TAK-875
TAK-875 50 mg	Experimental	Drug: TAK-875
Glimepiride	Active Comparator	Drug: Glimepiride
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAK-875	Drug		TAK-875 25 mg
TAK-875

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood glucose	Blood glucose	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant is an outpatient.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C557331	TAK-875
C057619	glimepiride

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Fukuoka	Fukuoka		Japan