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
3 other identifiers
interventional
207
1 country
25
Brief Summary
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus
Started Sep 2012
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedFirst Posted
Study publicly available on registry
September 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 31, 2023
August 1, 2023
1.2 years
August 31, 2012
August 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Glycosylated Hemoglobin (HbA1c)
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
16 weeks
Study Arms (3)
SYR-322 25 mg , AD-4833 15 mg
EXPERIMENTALSYR-322 25 mg , AD-4833 30 mg
EXPERIMENTALSYR-322 25 mg , AD-4833 placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (25)
Unknown Facility
Hirosaki-shi, Aomori, Japan
Unknown Facility
Kisaratsu-shi, Chiba, Japan
Unknown Facility
Matsuyama, Ehime, Japan
Unknown Facility
Fukuoka, Fukuoka, Japan
Unknown Facility
Kitakyushu-shi, Fukuoka, Japan
Unknown Facility
Kurume-shi, Fukuoka, Japan
Unknown Facility
Fukuyama-shi, Hiroshima, Japan
Unknown Facility
Hiroshima, Hiroshima, Japan
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Koga-shi, Ibaraki, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Kumamoto, Kumamoto, Japan
Unknown Facility
Miyazaki, Miyazaki, Japan
Unknown Facility
Suita-shi, Osaka, Japan
Unknown Facility
Koshigaya-shi, Saitama, Japan
Unknown Facility
Ōtsu, Shiga, Japan
Unknown Facility
Chiyoda-ku, Tokyo, Japan
Unknown Facility
Chuo-ku, Tokyo, Japan
Unknown Facility
Itabashi-ku, Tokyo, Japan
Unknown Facility
Meguro-ku, Tokyo, Japan
Unknown Facility
Minato-ku, Tokyo, Japan
Unknown Facility
Ohta-ku, Tokyo, Japan
Unknown Facility
Shinjuku-ku, Tokyo, Japan
Unknown Facility
Toyama, Toyama, Japan
Unknown Facility
Shimonoseki-shi, Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 18, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 31, 2023
Record last verified: 2023-08