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Double-blind Comparative Study of SYR-472

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. Identifier: NCT01632007
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: SYR-472 Drug: Alogliptin 25 mg Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Alogliptin

Arm Intervention/treatment
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

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT01632007

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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
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Study Director: Medical Director Takeda
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Takeda Identifier: NCT01632007    
Other Study ID Numbers: SYR-472/CCT-002
U1111-1128-6104 ( Registry Identifier: WHO )
JapicCTI-121839 ( Registry Identifier: JapicCTI )
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action