NCT01751360

Brief Summary

To evaluate the efficacy and safety of 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
14

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_3 diabetes-mellitus

Geographic Reach
1 country

1 active site

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

December 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

December 13, 2012

Last Update Submit

December 7, 2023

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose

    Blood Glucose

    7 days

Study Arms (1)

SYR-472 100mg

EXPERIMENTAL

SYR-472 100mg

Drug: SYR-472

Interventions

SYR-472DRUG
SYR-472 100mg

Eligibility Criteria

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

You may qualify if:

  • The participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
  • \. The participant can sign and date a written, informed consent form prior to the initiation of any study procedures.

You may not qualify if:

  • The participant has concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease
  • The participant is assessed to be ineligible for the study by the investigator or subinvestigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Suita-shi, Osaka, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

trelagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • General Manager

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

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 18, 2012

Study Start

April 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations

JP(1)