A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322

Takeda

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: AD-4833 15 mg; Drug: Placebo; Drug: AD-4833 30 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01686711

U1111-1132-3209 (Registry Identifier)

SYR-322-4833/CCT-901

JapicCTI-121916 (Registry Identifier)

Details and patient eligibility

About

To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.

Enrollment: 207 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
• Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion criteria

• Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
• Others who are assessed to be ineligible for the study by the investigator or subinvestigator.

Trial design

207 participants in 3 patient groups, including a placebo group

SYR-322 25 mg , AD-4833 15 mg

Experimental group

Treatment:

Drug: AD-4833 15 mg

SYR-322 25 mg , AD-4833 30 mg

Experimental group

Treatment:

Drug: AD-4833 30 mg

SYR-322 25 mg , AD-4833 placebo

Placebo Comparator group

Treatment:

Drug: Placebo