Study of Combination Therapy With SYR-322

Takeda

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus

Treatments: Drug: Alogliptin; Drug: Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01521962

U1111-1127-1525 (Registry Identifier)

SYR-322/CCT-901

JapicCTI-121736 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

67 participants in 2 patient groups, including a placebo group

SYR-322 (Alogliptin) QD

Experimental group

Description:

SYR-322 25 mg, orally.

Treatment:

Drug: Alogliptin

Insulin

Placebo Comparator group

Description:

injection

Treatment:

Drug: Insulin