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NCT01632007 Clinical Trial

Double-blind Comparative Study of SYR-472

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01632007
Other study ID # SYR-472/CCT-002
Secondary ID U1111-1128-6104J
Status Completed
Phase Phase 3
First received
Last updated
Start date May 1, 2012
Est. completion date July 1, 2013

Study information
Verified date December 2023
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date July 1, 2013
Est. primary completion date July 1, 2013
Accepts healthy volunteers
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SYR-472

• Alogliptin 25 mg

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glycosylated hemoglobin (HbA1c) Measurement of change in HbA1c (ratio of hemoglobin bound to glucose). 24 weeks.
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