NCT01433393

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus

Geographic Reach
1 country

19 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
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

First QC Date

September 12, 2011

Last Update Submit

November 7, 2012

Conditions

Diabetes Mellitus

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • HbA1c

Study Arms (3)

TAK-875 25 mg

EXPERIMENTAL
Drug: TAK-875

TAK-875 50 mg

EXPERIMENTAL
Drug: TAK-875

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TAK-875DRUG
TAK-875 25 mg
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 sub-investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Kisarazu-shi, Chiba, Japan

Location

Unknown Facility

Matsuyama, Ehime, Japan

Location

Unknown Facility

Fukuoka-shi Nishi-ku, Fukuoka, Japan

Location

Unknown Facility

Kasuga-shi, Fukuoka, Japan

Location

Unknown Facility

Naka, Ibaragi, Japan

Location

Unknown Facility

Tsuchiura-shi, Ibaragi, Japan

Location

Unknown Facility

Takamatsu, Kagawa-ken, Japan

Location

Unknown Facility

Kyoto-shi Fushimi-ku, Kyoto, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, Japan

Location

Unknown Facility

Kashihara-shi, Nara, Japan

Location

Unknown Facility

Kashiwara-shi, Osaka, Japan

Location

Unknown Facility

Osaka-shi Tsurumi-ku, Osaka, Japan

Location

Unknown Facility

Sakai-shi Nishi-ku, Osaka, Japan

Location

Unknown Facility

Shimotsuke-shi, Tochigi, Japan

Location

Unknown Facility

Chiyoda-ku, Tokyo, Japan

Location

Unknown Facility

Itabashi-ku, Tokyo, Japan

Location

Unknown Facility

Ōta-ku, Tokyo, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Unknown Facility

Toshima-ku, Tokyo, 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

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations

JP(19)