Type 2 Diabetes MellitusPhase 4BydureonNCT02533453

A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.

A Phase 4 study testing Bydureon in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 15 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 75 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Bydureon
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 15 sitesSouth Korea
Study dates: 28 Jan 2016to 7 Dec 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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;

Show all 13Show fewer

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)

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

South Korea15 sites

Research Site
Busan, 49241
Research Site
Daegu, 700-712
Research Site
Daejeon, 35015
Research Site
Gwangju, 61469
Research Site
Incheon, 405-760
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Seoul, 08308
Research Site
Seoul, 130-872
Research Site
Suwon, 16499
Research Site
Wŏnju, 26426

Other trials in South Korea

About this study

Official title: A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Bydureon
Keywords: Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BydureonBiological
Also called exenatide
exenatide once weekly

Study groups in NCT02533453
Study group	Role	What they receive
Bydureon	Experimental	exenatide once weekly Receives: Biological: Bydureon

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline and 12/24 weeks

Secondary outcomes (5)

Change in HbA1c
Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Measured: baseline and 12/24 weeks
Change in Fasting Plasma Gloucose
Change in Fasting plasma gloucose at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Measured: baseline and 12/24 weeks
Change in Body Weight
Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Measured: baseline and 12/24 weeks
Change in Vital Sign
Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Measured: baseline and 12/24 weeks
Evaluation of "Subjective Improvement of Main Indication"
"Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."
Measured: baseline and 12/24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 20167 Dec 2016

First posted26 Aug 2015 (estimated)
Study start28 Jan 2016
Primary completion7 Dec 2016
Study completion7 Dec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02533453
Sponsor's protocol ID: D5551L00018
Acronym: Bydureon
Status last verified: Feb 2019
First submitted: 11 Aug 2015
Last updated: 31 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
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Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
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Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02533453
Acronym / sponsor ID: Bydureon / D5551L00018
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 28 Jan 2016 (actual)
Primary completion: 7 Dec 2016 (actual)
Study completion: 7 Dec 2016 (actual)
First posted: 26 Aug 2015 (estimated)
Results: Posted 31 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Bydureon	Experimental	Biological: Bydureonexenatide once weekly

Who may qualify

Ages: 19 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (13 listed)

Has been treated, is currently being treated, or is expected to require or undergo treatment with any of the following medications:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BydureonAlso: exenatideexenatide once weekly	Biological	Bydureon

Primary outcome

Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
Time frame: baseline and 12/24 weeks
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.

5 secondary outcomes

Change in HbA1c
Time frame: baseline and 12/24 weeks
Change in Fasting Plasma Gloucose
Time frame: baseline and 12/24 weeks
Change in Body Weight
Time frame: baseline and 12/24 weeks
Change in Vital Sign
Time frame: baseline and 12/24 weeks
Evaluation of "Subjective Improvement of Main Indication"
Time frame: baseline and 12/24 weeks

Results and safety

Results posted to the registry on 31 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
12/24 Weeks Treatment	110	101

Primary outcome: Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)

Time frame: baseline and 12/24 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	12/24 Weeks Treatment n = 104
rate of all AEs	52.9 (42.9 to 62.6)
rate of all SAEs	3.8 (1.04 to 9.38)

Population analysed: Of 110 subjects, 104 were included in the safety set with 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks / 24 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
12/24 Weeks Treatment	4 of 104 (3.8%)	55 of 104 (52.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

RecruitingObservational study
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
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Recruiting
Starting Technology in At Risk Type 1 Diabetes Study
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Active, not recruiting
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Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
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Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bydureon in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 15 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs) (time frame: baseline and 12/24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02533453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.