NCT01433419

Brief Summary

The purpose of this study is to evaluate the safety and efficacy 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
333

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3 diabetes-mellitus

Geographic Reach
1 country

31 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

September 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 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

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

September 12, 2011

Last Update Submit

March 21, 2013

Conditions

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Adverse events

Study Arms (2)

TAK-875 25 mg

EXPERIMENTAL
Drug: TAK-875

TAK-875 50 mg

EXPERIMENTAL
Drug: TAK-875

Interventions

TAK-875 25 mg

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 sub-investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Unknown Facility

Katori-shi, Chiba, Japan

Location

Unknown Facility

Niihama-shi, Ehime, Japan

Location

Unknown Facility

Chikushino-shi, Fukuoka, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Onga-gun, Fukuoka, Japan

Location

Unknown Facility

Yukuhashi-shi, Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Chitose-shi, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Koga-shi, Ibaragi, Japan

Location

Unknown Facility

Ushiku-shi, Ibaragi, Japan

Location

Unknown Facility

Chigasaki-shi, Kanagawa, Japan

Location

Unknown Facility

Kamakura-shi, Kanagawa, Japan

Location

Unknown Facility

Minamata-shi, Kumamoto, Japan

Location

Unknown Facility

Yatsushiro-shi, Kumamoto, Japan

Location

Unknown Facility

Sasebo-shi, Nagasaki, Japan

Location

Unknown Facility

Kashihara-shi, Nara, Japan

Location

Unknown Facility

Okinawa-shi, Okinawa, Japan

Location

Unknown Facility

Izumi-shi, Osaka, Japan

Location

Unknown Facility

Suita-shi, Osaka, Japan

Location

Unknown Facility

Fujimi-shi, Saitama, Japan

Location

Unknown Facility

Shimotsuga-gun, Tochigi, Japan

Location

Unknown Facility

Komatsushima-shi, Tokushima, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, Japan

Location

Unknown Facility

Mitaka-shi, Tokyo, Japan

Location

Unknown Facility

Shibuya-ku, Tokyo, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Unknown Facility

Toshima-ku, Tokyo, Japan

Location

Unknown Facility

Shunan-shi, Yamaguchi, Japan

Location

Unknown Facility

Ube-shi, Yamaguchi, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

TAK-875

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2011

First Posted

September 14, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations