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Double-blind Comparative Study of SYR-472

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01632007
Enrollment
245
Registered
2012-06-29
Start date
2012-05-01
Completion date
2013-07-01
Last updated
2023-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

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

Interventions

DRUGAlogliptin 25 mg
DRUGPlacebo

Sponsors

Takeda
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Glycosylated hemoglobin (HbA1c)24 weeks.Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026