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NCT01521962 Clinical Trial

Study of Combination Therapy With SYR-322

Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01521962
Other study ID # SYR-322/CCT-901
Secondary ID U1111-1127-1525J
Status Completed
Phase Phase 3
First received January 26, 2012
Last updated November 12, 2013
Start date February 2012
Est. completion date March 2013

Study information
Verified date November 2013
Source Takeda
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

Intervention

Drug:
• Alogliptin
Alogliptin tablets
• Insulin
Insulin injection

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