Study of Combination Therapy With SYR-322

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Alogliptin; Drug: Insulin

• Registration Number: NCT01521962
• Lead Sponsor: Takeda

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-01-31
• Study Start: 2012-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-12
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYR-322 (Alogliptin) QD	Alogliptin	SYR-322 25 mg, orally.
Insulin	Insulin	injection

Primary Outcome Measures

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