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SYR-472 Open-label Study

This study is currently recruiting participants.
Verified January 2013 by Takeda Global Research & Development Center, Inc.
Sponsor:
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01751360
First received: December 13, 2012
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

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


Estimated Enrollment: 14
Study Start Date: December 2012
Estimated Primary Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751360

Contacts
Contact: Takeda Study Registration Call Center +1-800-778-2860 (USA & EU) medicalinformation@tpna.com

Locations
Japan
Recruiting
Suita-shi, Osaka, Japan
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
Study Director: General Manager Takeda Pharmaceutical Company Limited (Japan)
  More Information

No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
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: January 8, 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 May 22, 2013