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Completed

NCT Number: NCT02533453

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bydureon

Biological

exenatide once weekly

Other names: exenatide

Primary outcomes

  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 outcomes

  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."

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: Bydureon

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 26, 2015
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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