NCT01431807

Brief Summary

To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
680

participants targeted

Target at P75+ for phase_3 diabetes-mellitus

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

41 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

Study Start

First participant enrolled

September 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

1.8 years

First QC Date

September 8, 2011

Last Update Submit

December 7, 2023

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    52 weeks.

Study Arms (1)

SYR-472 group

EXPERIMENTAL

(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)

Drug: SYR-472

Interventions

SYR-472DRUG

oral, for up to 52 weeks.

SYR-472 group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
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.
  • Diabetes Mellitus

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 (41)

Unknown Facility

Akita, Akita, Japan

Location

Unknown Facility

Kisarazu-shi, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Munakata-shi, Fukuoka, Japan

Location

Unknown Facility

Koriyama-shi, Fukushima, Japan

Location

Unknown Facility

Gihu-shi, Gihu, Japan

Location

Unknown Facility

Fukuyama-shi, Hiroshima, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Eniwa-shi, Hokkaido, Japan

Location

Unknown Facility

Ishikari-shi, Hokkaido, Japan

Location

Unknown Facility

Nakagawa-gun, Hokkaido, Japan

Location

Unknown Facility

Obihiro-shi, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Mito, Ibaragi, Japan

Location

Unknown Facility

Naka, Ibaragi, Japan

Location

Unknown Facility

Takamatsu, Kagawa-ken, Japan

Location

Unknown Facility

Sagamihara-shi, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Tamana-shi, Kumamoto, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Nagano, Nagano, Japan

Location

Unknown Facility

Nagawaki-shi, Nagasaki, Japan

Location

Unknown Facility

Ōita, Oita Prefecture, Japan

Location

Unknown Facility

Minoh, Osaka, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Sakai-shi, Osaka, Japan

Location

Unknown Facility

Ageo-shi, Saitama, Japan

Location

Unknown Facility

Kawaguchi-shi, Saitama, Japan

Location

Unknown Facility

Koshigaya-shi, Saitama, Japan

Location

Unknown Facility

Kuki-shi, Saitama, Japan

Location

Unknown Facility

Saitama-shi, Saitama, Japan

Location

Unknown Facility

Suntou-gun, Shizuoka, Japan

Location

Unknown Facility

Oyama-shi, Tochigi, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Koganei-shi, Tokyo, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, Japan

Location

Unknown Facility

Shibuya-ku, Tokyo, Japan

Location

Unknown Facility

Tama-shi, Tokyo, Japan

Location

Unknown Facility

Tiyoda-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

trelagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Senior Director

    Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2011

First Posted

September 12, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

JP(41)