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Double-blind Comparative Study of SYR-472

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632007
First Posted: June 29, 2012
Last Update Posted: January 14, 2014
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
The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Condition Intervention Phase
Diabetes Mellitus Drug: SYR-472 Drug: Alogliptin 25 mg Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks. ]
    Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).


Estimated Enrollment: 245
Study Start Date: May 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYR-472 100 mg Drug: SYR-472
Active Comparator: Alogliptin 25 mg Drug: Alogliptin 25 mg
Other Name: SYR-322
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. The participant is an outpatient.
  2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

  1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.(e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
  2. The participant is considered ineligible for the study for any other reason 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): NCT01632007


Locations
Japan
Akita-shi, Akita, Japan
Matsudo-shi, Chiba, Japan
Fukuoka-shi, Fukuoka, Japan
Fukuyama-shi, Hiroshima, Japan
Ishikari-shi, Hokkaido, Japan
Nakagawa-gun, Hokkaido, Japan
Sapporo-shi, Hokkaido, Japan
Naka-shi, Ibaragi, Japan
Sagamihara-shi, Kanagawa, Japan
Kumamoto-shi, Kumamoto, Japan
Kashiwara-shi, Osaka, Japan
Osaka-shi, Osaka, Japan
Suita-shi, Osaka, Japan
Arakawa-ku, Tokyo, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Katsushika-ku, Tokyo, Japan
Mitaka-shi, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shunan-shi, Yamaguchi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01632007     History of Changes
Other Study ID Numbers: SYR-472/CCT-002
U1111-1128-6104 ( Registry Identifier: WHO )
JapicCTI-121839 ( Registry Identifier: JapicCTI )
First Submitted: June 27, 2012
First Posted: June 29, 2012
Last Update Posted: January 14, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Alogliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action