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Double-blind Comparative Study of SYR-472

This study is currently recruiting participants.
Verified June 2013 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01632007
First received: June 27, 2012
Last updated: June 17, 2013
Last verified: June 2013
History of Changes
  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: Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Alogliptin
U.S. FDA Resources

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
    Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).


Estimated Enrollment: 240
Study Start Date: May 2012
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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632007

Contacts
Contact: Takeda Study Registration Call Center +1-800-778-2860 medicalinformation@tpna.com

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

No publications provided

Responsible Party: Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier: NCT01632007     History of Changes
Other Study ID Numbers: SYR-472/CCT-002, U1111-1128-6104, JapicCTI-121839
Study First Received: June 27, 2012
Last Updated: June 17, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Alogliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013