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SYR-472 Open-label Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751360
First Posted: December 18, 2012
Last Update Posted: November 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  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

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Blood Glucose [ Time Frame: 7 days ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751360


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

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01751360     History of Changes
Other Study ID Numbers: SYR-472/OCT-002
U1111-1137-2768 ( Registry Identifier: UTN (WHO) )
JapicCTI-122024 ( Registry Identifier: JapicCTI (Japan) )
First Submitted: December 13, 2012
First Posted: December 18, 2012
Last Update Posted: November 7, 2013
Last Verified: November 2013

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