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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01686711

Enrollment

207

Registered

2012-09-18

Start date

2012-09-30

Completion date

2013-12-31

Last updated

2023-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

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

Interventions

DRUGAD-4833 15 mg

DRUGAD-4833 30 mg

DRUGPlacebo

Study design

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Glycosylated Hemoglobin (HbA1c)	16 weeks	Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026