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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02533453

Acronym

Bydureon

Enrollment

110

Registered

2015-08-26

Start date

2016-01-28

Completion date

2016-12-07

Last updated

2019-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

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

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.

Interventions

BIOLOGICALBydureon

exenatide once weekly

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 75 Years

Healthy volunteers

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

* 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)

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)	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.

Secondary

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

Countries

South Korea

Participant flow

Recruitment details

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

Pre-assignment details

115 subjects were participated: 5 failed screening without treatment with the study drug.

Participants by arm

Arm	Count
12/24 Weeks Treatment Exenatide 2mg / 12/24 weeks treatment	104
Total	104

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	6
Overall Study	Protocol Violation	1
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	12/24 Weeks Treatment
Age, Customized <50 years	44 Participants
Age, Customized >=70 years	2 Participants
Age, Customized Between 50 and 69 years	58 Participants
Sex: Female, Male Female	62 Participants
Sex: Female, Male Male	42 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	55 / 104
serious Total, serious adverse events	4 / 104

Outcome results

Primary

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.