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

February 14, 2019 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • 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, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bydureon
exenatide once weekly
Biological: Bydureon
exenatide once weekly
Other Names:
  • exenatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 12/24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline and 12/24 weeks
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)
baseline and 12/24 weeks
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)
baseline and 12/24 weeks
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)
baseline and 12/24 weeks
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."
baseline and 12/24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2016

Primary Completion (Actual)

December 7, 2016

Study Completion (Actual)

December 7, 2016

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Actual)

May 31, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5551L00018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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