Trial Outcomes & Findings for A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients. (NCT NCT02533453)
NCT ID: NCT02533453
Last Updated: 2019-05-31
Results Overview
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.
COMPLETED
PHASE4
110 participants
baseline and 12/24 weeks
2019-05-31
Participant Flow
Participants recruited from 15 hospitals in South Korea between Jan 2016 and Jul 2016.
115 subjects were participated: 5 failed screening without treatment with the study drug.
Participant milestones
| Measure |
12/24 Weeks Treatment
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
12/24 Weeks Treatment
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Baseline characteristics by cohort
| Measure |
12/24 Weeks Treatment
n=104 Participants
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Age, Customized
<50 years
|
44 Participants
n=99 Participants
|
|
Age, Customized
Between 50 and 69 years
|
58 Participants
n=99 Participants
|
|
Age, Customized
>=70 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: baseline and 12/24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
12/24 Weeks Treatment
n=104 Participants
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
rate of all AEs
|
52.9 percentage of participants
Interval 42.9 to 62.6
|
|
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
rate of all SAEs
|
3.8 percentage of participants
Interval 1.04 to 9.38
|
SECONDARY outcome
Timeframe: baseline and 12/24 weeksPopulation: 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. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set.
Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Outcome measures
| Measure |
12/24 Weeks Treatment
n=103 Participants
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Change in HbA1c
|
-1.21 percentage of Hba1c
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: baseline and 12/24 weeksPopulation: 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. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set.
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)
Outcome measures
| Measure |
12/24 Weeks Treatment
n=103 Participants
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Change in Fasting Plasma Gloucose
|
-34.2 mg/dL
Standard Deviation 48.3
|
SECONDARY outcome
Timeframe: baseline and 12/24 weeksPopulation: Of 110 subjects, 104 were included in the safety set with 5 subjects of non-treatment with the study drug, 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded.
Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Outcome measures
| Measure |
12/24 Weeks Treatment
n=104 Participants
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Change in Body Weight
|
-0.95 kg
Standard Deviation 2.86
|
SECONDARY outcome
Timeframe: baseline and 12/24 weeksPopulation: Of 110 subjects, 104 were included in the safety set with 5 subjects of non-treatment with the study drug, 3 of inclusion/exclusion criteria deviations, 2 of treatment with prohibited concomitant medications, and 1 of enrolment before IRB approval excluded.
Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Outcome measures
| Measure |
12/24 Weeks Treatment
n=104 Participants
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Change in Vital Sign
SBP
|
-3.35 mmHg
Standard Deviation 11.95
|
|
Change in Vital Sign
DBP
|
-0.15 mmHg
Standard Deviation 9.58
|
SECONDARY outcome
Timeframe: baseline and 12/24 weeksPopulation: 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. Of 104 subjects, 1 subject who failed to receive the efficacy analysis was excluded, and 103 were included in the efficacy set.
"Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."
Outcome measures
| Measure |
12/24 Weeks Treatment
n=103 Participants
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Evaluation of "Subjective Improvement of Main Indication"
Improved
|
84 participants
|
|
Evaluation of "Subjective Improvement of Main Indication"
Slightly improved
|
11 participants
|
|
Evaluation of "Subjective Improvement of Main Indication"
Unchanged
|
6 participants
|
|
Evaluation of "Subjective Improvement of Main Indication"
Aggravated
|
1 participants
|
|
Evaluation of "Subjective Improvement of Main Indication"
unable to evaluate
|
1 participants
|
Adverse Events
12/24 Weeks Treatment
Serious adverse events
| Measure |
12/24 Weeks Treatment
n=104 participants at risk
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumor
|
0.96%
1/104 • Number of events 1 • 12 weeks / 24 weeks
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.
|
|
Infections and infestations
Acute gastroenteritis
|
0.96%
1/104 • Number of events 1 • 12 weeks / 24 weeks
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.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.96%
1/104 • Number of events 1 • 12 weeks / 24 weeks
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.
|
|
Metabolism and nutrition disorders
Hyperglycemia including diarrhea
|
0.96%
1/104 • Number of events 1 • 12 weeks / 24 weeks
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.
|
Other adverse events
| Measure |
12/24 Weeks Treatment
n=104 participants at risk
Exenatide 2mg / 12/24 weeks treatment
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
14.4%
15/104 • Number of events 16 • 12 weeks / 24 weeks
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.
|
|
General disorders
Injection site nodule
|
15.4%
16/104 • Number of events 16 • 12 weeks / 24 weeks
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.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
9/104 • Number of events 17 • 12 weeks / 24 weeks
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
7/104 • Number of events 11 • 12 weeks / 24 weeks
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.
|
|
General disorders
injection site pruritus
|
7.7%
8/104 • Number of events 8 • 12 weeks / 24 weeks
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.
|
|
Nervous system disorders
Dizziness
|
5.8%
6/104 • Number of events 10 • 12 weeks / 24 weeks
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.
|
|
Nervous system disorders
Headache
|
5.8%
6/104 • Number of events 10 • 12 weeks / 24 weeks
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.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.7%
7/104 • Number of events 10 • 12 weeks / 24 weeks
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.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.8%
6/104 • Number of events 8 • 12 weeks / 24 weeks
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.
|
Additional Information
Hyun Jung Kang / Local Study Leader
Astrazeneca, Korea
Results disclosure agreements
- Principal investigator is a sponsor employee * The Institution and PI shall provide the Company with copies of any materials relating to the Study that either intends to publish (or submit for publication) or make any presentations relating to, at least 30 days in advance of publication * At the request of the Company, the Institution and PI shall withhold publication for a period of 90 days from the date on which the Company receives the material.
- Publication restrictions are in place
Restriction type: OTHER