Double-blind Comparative Study of SYR-472
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
- Time Frame: 24 weeks.
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
Additional Information on this Clinical Trial
Information obtained from ClinicalTrials.gov on May 16, 2013
Link to the current ClinicalTrials.gov record. - http://clinicaltrials.gov/show/NCT01632007
Study ID Number: SYR-472/CCT-002
ClinicalTrials.gov Identifier: NCT01632007
Health Authority: Japan: Ministry of Health, Labor and Welfare