Diabetes Mellitus Type 2NCT02090673
Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea
An observational study of Diabetes Mellitus Type 2, run by AstraZeneca at 1 site in South Korea.
Trial summary
The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Exenatide
- How many people
- 1,711 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2009to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic, hospital and teaching hospitals
Who may be able to join
- Male or female at least 18 years of age
- Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
- Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information
Who cannot join
- Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
- Are pregnant or have intentions of becoming pregnant within the duration of the study
- Contraindications
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Exenatide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
| Study group | Role | What they receive |
|---|---|---|
| Group1:Type 2 diabetic patients treated with Exenatide therapy | Korean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus
Measured: At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks
Secondary outcomes (4)
Change from baseline to endpoint in Hemoglobin A1c (HbA1c)
Measured: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in Body weight
Measured: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in Fasting plasma glucose
Measured: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in subjective measures include improvement of main indication
Measured: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startFeb 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,711 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090673
- Sponsor's protocol ID
- MB001-078
- Status last verified
- Aug 2015
- First submitted
- 17 Mar 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hwang YC, Kim A, Jo E, Yang Y, Cho JH, Lee BW. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice. BMC Endocr Disord. 2017 Oct 25;17(1):68. doi: 10.1186/s12902-017-0220-4.
PubMed 29065865
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance Study: 12 To 24 Weeks Study On The Treatment Emergent Adverse Events In Patients With Type 2 Diabetes Taking Exenatide In Korea
- ClinicalTrials.gov ID
- NCT02090673
- Acronym / sponsor ID
- MB001-078
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,711 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Exenatide through collecting, reviewing, identifying and verifying the safety and effectiveness information about Exenatide in general practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1:Type 2 diabetic patients treated with Exenatide therapy | – | Drug: ExenatideKorean patients who are at least 18 years old, diagnosed with type 2 diabetes, and are treated with Exenatide in an ambulatory care setting according to the approved label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic, hospital and teaching hospitals
Key inclusion criteria (3 listed)
- Male or female at least 18 years of age
- Patients who are to initiate Exenatide treatment for type 2 diabetes at baseline, following their treating physicians' advice
- Patients, who in the opinion of the treating physicians, comply with all the recommendations stated in the relevant product information
Key exclusion criteria (3 listed)
- Are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug
- Are pregnant or have intentions of becoming pregnant within the duration of the study
- Contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exenatide | Drug | Group1:Type 2 diabetic patients treated with Exenatide therapy |
Primary outcome
The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus
Time frame: At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks
4 secondary outcomes
Change from baseline to endpoint in Hemoglobin A1c (HbA1c)
Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in Body weight
Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in Fasting plasma glucose
Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Change from baseline to endpoint in subjective measures include improvement of main indication
Time frame: Baseline (Day 1) and 12 or 24 weeks ± 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
- Derived from this study: PubMed 29065865Hwang YC, Kim A, Jo E, Yang Y, Cho JH, Lee BW. Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice. BMC Endocr Disord. 2017 Oct 25;17(1):68. doi: 10.1186/s12902-017-0220-4.
- CSR\_Synopsis\_MB001-078.pdfLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2, run by AstraZeneca at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in patients who are treated with Exenatide for type 2 diabetes mellitus (time frame: At 12 weeks ± 4 weeks or 24 weeks ± 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02090673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.