A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy

SYR-322-4833/CCT-901

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

2012-09-01

2013-12-01

2013-12-01

Completed

Early phase I

207

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 207, 'type': 'ACTUAL'}}

2023-08-31