A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Bydureon
1 other identifier
interventional
110
1 country
15
Brief Summary
As current study is conducted to provide additional information regarding safety and efficacy Bydureon, exenatide once weekly for injectable suspension, in the Korean population open label, non-comparative, multi-centre design is used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 type-2-diabetes-mellitus
Started Jan 2016
Shorter than P25 for phase_4 type-2-diabetes-mellitus
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2015
CompletedFirst Posted
Study publicly available on registry
August 26, 2015
CompletedStudy Start
First participant enrolled
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2016
CompletedResults Posted
Study results publicly available
May 31, 2019
CompletedMay 31, 2019
February 1, 2019
10 months
August 11, 2015
October 10, 2017
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
was to estimate the incidence rates of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with 2 mg exenatide once weekly for type 2 diabetes mellitus in the normal clinical practice setting over a period of 12/24 weeks for long-term surveillance.
baseline and 12/24 weeks
Secondary Outcomes (5)
Change in HbA1c
baseline and 12/24 weeks
Change in Fasting Plasma Gloucose
baseline and 12/24 weeks
Change in Body Weight
baseline and 12/24 weeks
Change in Vital Sign
baseline and 12/24 weeks
Evaluation of "Subjective Improvement of Main Indication"
baseline and 12/24 weeks
Study Arms (1)
Bydureon
EXPERIMENTALexenatide once weekly
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, 19-75 years of age
- diagnosed with type 2 diabetes mellitus
- Patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies;
- Metformin
- Sulphonylurea
- Thiazolidinedione
- Metformin and sulphonylurea
- Metformin and thiazolidinedione
You may not qualify if:
- Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:
- Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
- Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
- DPP-4 inhibitors within 30 days of screening;
- Regular use (\> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
- Regular use (\> 14 days) of systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have a high rate of systemic absorption within 3 months of screening;
- GLP-1 receptor agonist except exenatide within 3 months of screening;
- diagnosed with type 1 diabetes mellitus or diabetic ketoacidosis;
- type 2 diabetes by beta-cell dysfunction requiring insulin treatment
- Has ever used exenatide
- Pregnant or breast feeding patients
- Hepatic disease (defined by aspartate or alanine transaminase \>3.0 times the upper limit of normal
- End-stage renal disease or severe renal impairment (creatinine clearance \< 30 ml/min)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Busan, 49241, South Korea
Research Site
Daegu, 700-712, South Korea
Research Site
Daejeon, 35015, South Korea
Research Site
Gwangju, 61469, South Korea
Research Site
Incheon, 405-760, South Korea
Research Site
Seongnam-si, 13620, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 08308, South Korea
Research Site
Seoul, 130-872, South Korea
Research Site
Suwon, 16499, South Korea
Research Site
Wŏnju, 26426, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hyun Jung Kang / Local Study Leader
- Organization
- Astrazeneca, Korea
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2015
First Posted
August 26, 2015
Study Start
January 28, 2016
Primary Completion
December 7, 2016
Study Completion
December 7, 2016
Last Updated
May 31, 2019
Results First Posted
May 31, 2019
Record last verified: 2019-02