Clinical trial NCT02533453: A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-08-26
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
timeFrame: baseline and 12/24 weeks
Secondary outcomes:
measure: Change in HbA1c
timeFrame: baseline and 12/24 weeks
measure: Change in Fasting Plasma Gloucose
timeFrame: baseline and 12/24 weeks
measure: Change in Body Weight
timeFrame: baseline and 12/24 weeks
measure: Change in Vital Sign
timeFrame: baseline and 12/24 weeks
measure: Evaluation of "Subjective Improvement of Main Indication"
timeFrame: baseline and 12/24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suwon-si
country: Korea, Republic of
facility: Research Site
city: Wonju-si
country: Korea, Republic of
facility: Research Site
Study officials:
References: