Type 2 Diabetes MellitusONGLYZA PMSNCT01223456
Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 11 sites in Philippines.
Trial summary
This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician. 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
- 542 participants
- Where
- 11 sitesPhilippines
- Study dates
- Oct 2010to Dec 2012
- 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: several private and government hospitals
Who may be able to join
- Diagnosis of Type 2 Diabetes Mellitus
- Prescribed Saxagliptin by patient's attending physician
Who cannot join
- Known allergic or serious adverse reaction to Saxagliptin
- Pregnant or breastfeeding patients
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Philippines11 sites
Research Site
Batangas, Batangas
Research Site
Cebu City, Cebu
Research Site
Davao City, Davao Region
Research Site
Iloilo City, Iloilo
Research Site
Las Piñas, Manila
Research Site
Mabalacat, Pampanga
Research Site
Makati, Manila
Research Site
Manila, Manila
Research Site
Manila
Research Site
Pasig, Manila
Research Site
Quezon City, Manila
About this study
Official title: A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines
This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Saxagliptin, type 2 diabetes, clinical practice
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events observed during the treatment duration
Measured: Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up
Clinical Response determined by cure rate
Measured: Up to three (3) months after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Inability to recruit adequate number of patients within the specified time period.
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
- Time perspective
- Prospective
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milagros Tan, MD, Study director, AstraZeneca PhilippinesEmmanuel Arca, MD, Study chair, AstraZeneca Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223456
- Sponsor's protocol ID
- NIS-CPH-DUM-2010/1
- Acronym
- ONGLYZA PMS
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2010
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Descriptive Study of the Efficacy and Safety of ONGLYZA (Saxagliptin) Under Conditions of Actual Use in the Philippines
- ClinicalTrials.gov ID
- NCT01223456
- Acronym / sponsor ID
- ONGLYZA PMS / NIS-CPH-DUM-2010/1
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Saxagliptin, type 2 diabetes, clinical practice
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to recruit adequate number of patients within the specified time period.
- Enrolment
- 542 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Oct 2010 (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 post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- several private and government hospitals
Key inclusion criteria (2 listed)
- Diagnosis of Type 2 Diabetes Mellitus
- Prescribed Saxagliptin by patient's attending physician
Key exclusion criteria (2 listed)
- Known allergic or serious adverse reaction to Saxagliptin
- Pregnant or breastfeeding patients
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
Adverse events observed during the treatment duration
Time frame: Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up
Clinical Response determined by cure rate
Time frame: Up to three (3) months after initiation of treatment
Results and safety
The study was stopped early (reason given: Inability to recruit adequate number of patients within the specified time period.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
Milagros Tan, MD study director
AstraZeneca Philippines
Emmanuel Arca, MD study chair
AstraZeneca Philippines
11 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 11 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 was stopped early (reason given: Inability to recruit adequate number of patients within the specified time period.). Results are not available in the source record.
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?
Adverse events observed during the treatment duration (time frame: Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up). The study lists 2 primary outcomes in all. 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 8 Oct 2013.