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

Type 2 Diabetes Mellitus Clinical Trial

— Bydureon  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533453
• Other study ID #: D5551L00018
• Status: Completed
• Phase: Phase 4
• Start date: January 28, 2016
• Est. completion date: December 7, 2016

Study information

• Verified date: February 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 7, 2016
• Est. primary completion date: December 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Biological:
• Bydureon
exenatide once weekly

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Seongnam-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Korea, Republic of	Research Site	Wonju-si

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	baseline and 12/24 weeks
Secondary	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)	baseline and 12/24 weeks
Secondary	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)	baseline and 12/24 weeks
Secondary	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)	baseline and 12/24 weeks
Secondary	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)	baseline and 12/24 weeks
Secondary	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."	baseline and 12/24 weeks