SYR-472 Open-label Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01751360
First received: December 13, 2012
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus
Drug: SYR-472
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Blood Glucose [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Blood Glucose


Enrollment: 14
Study Start Date: April 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYR-472 100mg
SYR-472 100mg
Drug: SYR-472

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-1. The participant is judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.

2. The participant can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria:

-1. The participant has concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease

. 2. The participant is assessed to be ineligible for the study by the investigator or subinvestigator.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751360

Locations
Japan
Suita-shi, Osaka, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01751360     History of Changes
Other Study ID Numbers: SYR-472/OCT-002, U1111-1137-2768, JapicCTI-122024
Study First Received: December 13, 2012
Last Updated: November 5, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014