Type 2 Diabetes MellitusNCT00622323
Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 3 sites in Philippines.
Trial summary
This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 41 participants
- Where
- 3 sitesPhilippines
- Study dates
- Feb 2008to Sep 2009
- 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: Male and female patients at least 18 years of age and diagnosed with type 2 diabetes mellitus treated in an ambulatory care setting and who are taking metformin, a sulfonylurea, or a combination of metformin and sulfonylurea, but have not achieved adequate glycemic control. Female patients eligible of becoming pregnant are required to have some form of contraception while participating in the study.
Who may be able to join
- are male or female outpatients at least 18 years of age
- provide written consent to the release of their data after being informed of the study
- diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both
- are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care
- are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient
Who cannot join
- are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
- are currently taking insulin.
- are pregnant or have intentions of becoming pregnant within the duration of the study.
- are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.
Trial locations and contacts
3 sites in 1 country.
Philippines3 sites
Research Site
Paranaque City
Research Site
Pasig
Research Site
Taytay
About this study
This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, exenatide, metformin, sulfonylurea, Byetta, Amylin, Lilly
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide
Measured: 12 weeks
Secondary outcomes (1)
To evaluate the change from baseline to endpoint in HbA1c and body weight of Filipino patients with type 2 diabetes mellitus treated with exenatide who are taking metformin and/or a sulfonylurea but have not achieved adequate glycemic control.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, MD, Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622323
- Sponsor's protocol ID
- H8O-PH-B006
- Other IDs
- H8O-PH-B006
- Status last verified
- Oct 2016
- First submitted
- 14 Feb 2008
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study of Byetta ™ (Exenatide) Use Among Filipino Patients
- ClinicalTrials.gov ID
- NCT00622323
- Acronym / sponsor ID
- H8O-PH-B006
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- diabetes, exenatide, metformin, sulfonylurea, Byetta, Amylin, Lilly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Feb 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Feb 2008 (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.
This is a prospective, non-interventional, post marketing surveillance study to determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, serious and non-serious, that would occur among Filipino patients with type 2 diabetes mellitus who are treated with exenatide who are taking metformin, a sulfonylurea or a combination of metformin and a sulfonylurea but have not achieved adequate glycemic control.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients at least 18 years of age and diagnosed with type 2 diabetes mellitus treated in an ambulatory care setting and who are taking metformin, a sulfonylurea, or a combination of metformin and sulfonylurea, but have not achieved adequate glycemic control. Female patients eligible of becoming pregnant are required to have some form of contraception while participating in the study.
Key inclusion criteria (5 listed)
- are male or female outpatients at least 18 years of age
- provide written consent to the release of their data after being informed of the study
- diagnosed with type 2 diabetes mellitus and are taking metformin, or a sulfonylurea or both
- are reliable, and agree to keep all appointments for clinic visits, complete tests and procedures as may be required by the attending physician in the course of routine clinical care
- are treated with exenatide according to the approved Product Insert, as prescribed by the investigator in the routine care of the patient
Key exclusion criteria (4 listed)
- are simultaneously participating in a different study that includes a treatment intervention and/or an investigational drug.
- are currently taking insulin.
- are pregnant or have intentions of becoming pregnant within the duration of the study.
- are the investigators or their immediate families. Immediate family is defined as the investigator's spouse, parents, natural or legally adopted child (including stepchild living in the investigator's household), grandparents, or grandchild. Employees of investigators are also not eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide
Time frame: 12 weeks
1 secondary outcome
To evaluate the change from baseline to endpoint in HbA1c and body weight of Filipino patients with type 2 diabetes mellitus treated with exenatide who are taking metformin and/or a sulfonylurea but have not achieved adequate glycemic control.
Time frame: 12 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 26 Oct 2016.
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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.
Chief Medical Officer, MD study director
Eli Lilly and Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 3 sites in Philippines.
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 5 inclusion and 4 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Philippines. 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?
To determine the proportion of patients experiencing an adverse event and a list of the experienced adverse events, that would occur among Filipino patients with type 2 diabetes and inadequate glycemic control treated with exenatide (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2016.