NCT01585792

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 16, 2013

Status Verified

April 1, 2013

Enrollment Period

7 months

First QC Date

April 24, 2012

Last Update Submit

April 15, 2013

Conditions

Diabetic Patients

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Blood glucose

    4 weeks

Study Arms (4)

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

TAK-875DRUG
TAK-875 25 mg
GlimepirideDRUG
Glimepiride
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Sumida-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

TAK-875glimepiride

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2012

First Posted

April 26, 2012

Study Start

May 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 16, 2013

Record last verified: 2013-04

Locations

JP(2)