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Double-blind Comparative Study of SYR-472

Dates, Status, Enrollment

Brief Summary

Skip to Participation Criteria

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

  • Study Type: Interventional
  • Study Design: Primary Purpose: Treatment

Interventions Used in this Clinical Trial

  • Drug: SYR-472
  • Drug: Alogliptin 25 mg
  • Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: SYR-472 100 mg
  • Active Comparator: Alogliptin 25 mg
  • Placebo Comparator: Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Glycosylated hemoglobin (HbA1c)
    • Time Frame: 24 weeks.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Clinical Trial Investigator Information

  • Lead Sponsor
    • Takeda Pharmaceutical Company Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Director, Study Director, Takeda Pharmaceutical Company Limited
  • Overall Contact(s)
    • Takeda Study Registration Call Center, +1-800-778-2860, medicalinformation@tpna.com