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CompletedNCT02533453BydureonUpdated May 31, 2019Results posted

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 interventional study of Bydureon in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 15 sites in South Korea. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-31.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
110
Allocation
Not applicable
Ages
19 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide
03

In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's enrollment of 110 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

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

    1. Alpha glucosidase inhibitor or meglitinide within 30 days of screening;
    2. Insulin within 2 weeks prior to screening or insulin for longer than 1 week within 3 months of screening;
    3. DPP-4 inhibitors within 30 days of screening;
    4. Regular use (> 14 days) of drugs that directly affect gastrointestinal motility within 3 months of screening;
    5. 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;
    6. 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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Bydureon

    exenatide once weekly

    Biological: Bydureon

Interventions

  • BiologicalBydureon

    exenatide once weekly

    Also known as: exenatide

06

What researchers measure

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.

    Time frame: baseline and 12/24 weeks

Secondary outcomes

  1. 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)

    Time frame: baseline and 12/24 weeks

  2. 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)

    Time frame: baseline and 12/24 weeks

  3. 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)

    Time frame: baseline and 12/24 weeks

  4. 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)

    Time frame: baseline and 12/24 weeks

  5. 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."

    Time frame: baseline and 12/24 weeks

07

Results

Posted May 31, 2019

Participant flow

Participants recruited from 15 hospitals in South Korea between Jan 2016 and Jul 2016.

Participant flow — Overall Study
Milestone12/24 Weeks Treatment
Started110
Completed101
Not completed9
Withdrew: Adverse event6
Withdrew: Protocol violation1
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryPercentage 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.

Time frame:
baseline and 12/24 weeks
Reported as:
Number · percentage of participants
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
percentage of participants12/24 Weeks Treatment
rate of all AEs52.9 (42.9 to 62.6)
rate of all SAEs3.8 (1.04 to 9.38)
SecondaryChange 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)

Time frame:
baseline and 12/24 weeks
Reported as:
Mean · percentage of Hba1c
Change in HbA1c
percentage of Hba1c12/24 Weeks Treatment
Change in HbA1c-1.21 ± 1.10
SecondaryChange 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)

Time frame:
baseline and 12/24 weeks
Reported as:
Mean · mg/dL
Change in Fasting Plasma Gloucose
mg/dL12/24 Weeks Treatment
Change in Fasting Plasma Gloucose-34.2 ± 48.3
SecondaryChange 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)

Time frame:
baseline and 12/24 weeks
Reported as:
Mean · kg
Change in Body Weight
kg12/24 Weeks Treatment
Change in Body Weight-0.95 ± 2.86
SecondaryChange 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)

Time frame:
baseline and 12/24 weeks
Reported as:
Mean · mmHg
Change in Vital Sign
mmHg12/24 Weeks Treatment
SBP-3.35 ± 11.95
DBP-0.15 ± 9.58
SecondaryEvaluation of "Subjective Improvement of Main Indication"

"Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."

Time frame:
baseline and 12/24 weeks
Reported as:
Number · participants
Evaluation of "Subjective Improvement of Main Indication"
participants12/24 Weeks Treatment
Improved84
Slightly improved11
Unchanged6
Aggravated1
unable to evaluate1

Adverse events

Collected over 12 weeks / 24 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
12/24 Weeks Treatment—4/104 (3.8%)55/104 (52.9%)
Most frequent serious events
Most frequent serious events
Event12/24 Weeks Treatment
Neuroendocrine tumorNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/104
Acute gastroenteritisInfections and infestations1/104
Pelvic inflammatory diseaseInfections and infestations1/104
Hyperglycemia including diarrheaMetabolism and nutrition disorders1/104
Most frequent other events
Most frequent other events
Event12/24 Weeks Treatment
Injection site noduleGeneral disorders16/104
NauseaGastrointestinal disorders15/104
VomitingGastrointestinal disorders9/104
injection site pruritusGeneral disorders8/104
DiarrhoeaGastrointestinal disorders7/104
HypoglycaemiaMetabolism and nutrition disorders7/104
DizzinessNervous system disorders6/104
HeadacheNervous system disorders6/104
Decreased appetiteMetabolism and nutrition disorders6/104

Baseline characteristics

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

Age, Customized
Age, Customized(Participants)12/24 Weeks Treatment
<50 years44
Between 50 and 69 years58
>=70 years2
Sex: Female, Male
Sex: Female, Male(Participants)12/24 Weeks Treatment
Female62
Male42
08

Study locations

15 sites
  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02533453
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 26, 2015
Start date
Jan 28, 2016
Primary completion
Dec 7, 2016
Completion
Dec 7, 2016
Results posted
May 31, 2019
Last update
May 31, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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