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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 T2DM Patients. (Bydureon)

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ClinicalTrials.gov Identifier: NCT02533453
Recruitment Status : Completed
First Posted : August 26, 2015
Results First Posted : May 31, 2019
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Biological: Bydureon Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 28, 2016
Actual Primary Completion Date : December 7, 2016
Actual Study Completion Date : December 7, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bydureon
exenatide once weekly
 Biological: Bydureon
exenatide once weekly
Other Name: exenatide


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs) [ Time Frame: 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 Outcome Measures :
  1. Change in HbA1c [ Time Frame: 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)

  2. Change in Fasting Plasma Gloucose [ Time Frame: 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)

  3. Change in Body Weight [ Time Frame: 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)

  4. Change in Vital Sign [ Time Frame: 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)

  5. Evaluation of "Subjective Improvement of Main Indication" [ Time Frame: baseline and 12/24 weeks ]
    "Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533453


Locations
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Korea, Republic of
Research Site
Busan, Korea, Republic of, 49241
Research Site
Daegu, Korea, Republic of, 700-712
Research Site
Daejeon, Korea, Republic of, 35015
Research Site
Gwangju, Korea, Republic of, 61469
Research Site
Incheon, Korea, Republic of, 405-760
Research Site
Seongnam-si, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 03722
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Seoul, Korea, Republic of, 06351
Research Site
Seoul, Korea, Republic of, 06591
Research Site
Seoul, Korea, Republic of, 08308
Research Site
Seoul, Korea, Republic of, 130-872
Research Site
Suwon-si, Korea, Republic of, 16499
Research Site
Wonju-si, Korea, Republic of, 26426
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02533453    
Other Study ID Numbers: D5551L00018
First Posted: August 26, 2015    Key Record Dates
Results First Posted: May 31, 2019
Last Update Posted: May 31, 2019
Last Verified: February 2019
Keywords provided by AstraZeneca:
Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide
Additional relevant MeSH terms:
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Exenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists