search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Bydureon
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bydureon

Arm Description

exenatide once weekly

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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)
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)
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."

Full Information

First Posted
August 11, 2015
Last Updated
February 14, 2019
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT02533453
Brief Title
A 12/24-weeks, Open, Multi-centre, Phase IV Study on Safety and Efficacy of 2mg Exenatide Once Weekly (Bydureon) in T2DM Patients.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 28, 2016 (Actual)
Primary Completion Date
December 7, 2016 (Actual)
Study Completion Date
December 7, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, T2DM, GLP-1, GLP-1 Once weekly, Exenatide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bydureon
Arm Type
Experimental
Arm Description
exenatide once weekly
Intervention Type
Biological
Intervention Name(s)
Bydureon
Other Intervention Name(s)
exenatide
Intervention Description
exenatide once weekly
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events(AEs) and Serious Adverse Event(SAEs)
Description
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.
Time Frame
baseline and 12/24 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1c
Description
Change in HbA1c at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Time Frame
baseline and 12/24 weeks
Title
Change in Fasting Plasma Gloucose
Description
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)
Time Frame
baseline and 12/24 weeks
Title
Change in Body Weight
Description
Change in body weight at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Time Frame
baseline and 12/24 weeks
Title
Change in Vital Sign
Description
Change in vital sign at 12 and 24 weeks from start of the treatment(24 weeks just for patients allocated in long-term treatment)
Time Frame
baseline and 12/24 weeks
Title
Evaluation of "Subjective Improvement of Main Indication"
Description
"Subjective improvement of main indication" will be assessed as "improved," "slightly improved," "unchanged," "aggravated," or "unable to evaluate."
Time Frame
baseline and 12/24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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)
Facility Information:
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Research Site
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Research Site
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju-si
ZIP/Postal Code
26426
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs