Study of Combination Therapy With SYR-322

A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01521962

Enrollment

Registered

2012-01-31

Start date

2012-02-29

Completion date

2013-03-31

Last updated

2013-11-13

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

Conditions

Diabetes Mellitus

Brief summary

To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.

Interventions

DRUGInsulin

Insulin injection

DRUGAlogliptin

Alogliptin tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

1. The subject is an outpatient. 2. The subject 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 subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. 2. The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Design outcomes

Primary

Measure	Time frame
Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)	Baseline and Week 12

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026