Double-blind Comparative Study of SYR-472

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: SYR-472; Drug: Alogliptin 25 mg; Drug: Placebo

• Registration Number: NCT01632007
• Lead Sponsor: Takeda

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-01
• Study First Submitted: 2012-06-27
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Primary Completion: 2013-07-01
• Study Completion: 2013-07-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SYR-472 100 mg	SYR-472	-
Alogliptin 25 mg	Alogliptin 25 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Glycosylated hemoglobin (HbA1c)	24 weeks.	Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).