NCT Number: NCT01632007
Double-blind Comparative Study of SYR-472
The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.
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Notify MeKey information
Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Akita, Japan
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The participant is an outpatient.
- 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
- 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)
- The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Treatment and study plan
Alogliptin 25 mg
DrugOther names: SYR-322
Placebo
DrugPrimary outcomes
-
Glycosylated hemoglobin (HbA1c)
Time frame: 24 weeks.
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).
Sponsors and collaborators
Lead sponsor
Takeda
Industry
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Jun 29, 2012
- Registry last updated
- Dec 11, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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