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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Biological: Bydureon


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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bydureon<br>exenatide once weekly | Biological: Bydureon<br>* exenatide once weekly<br>* Other names: exenatide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide