Type 2 Diabetes MellitusREALITYNCT02355145
Non-inteRvEntional Study to Observe rAtionaLe to Select add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin.
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 3 sites in Bulgaria.
Trial summary
A non-interventional, multicentre study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. 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
- 1,005 participants
- Where
- 3 sitesBulgaria
- Study dates
- 2 Apr 2015to 28 Jul 2016
- 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: Type 2 diabetes patients, inadequately controlled with metformin, with a current treatment based on any add-on (non-insulin) diabetes therapy.
Who may be able to join
- Provision of subject informed consent
- Female and/or male aged 18 years and over
- Diagnosis of type 2 diabetes mellitus
- Patients considered inadequately controlled with metformin with a current treatment based on any add-on diabetes therapy
Who cannot join
- Diagnosis of type 1 diabetes
- Current antidiabetes treatment with oral monotherapy
- Insulin treatment for type 2 diabetes
- Current participation in any clinical trial
- Patient who have been enrolled in the study at point 1 can not be enrolled at point 2
Trial locations and contacts
3 sites in 1 country.
Bulgaria3 sites
Research Site
Pleven
Research Site
Sofia
Research Site
Stara Zagora
About this study
Official title: REALITY: A Non-inteRvEntional Study to Observe the rAtionaLe of selectIng add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin in Real-life Practice at 1 Year Distance
A non-interventional, multicentre study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Data will be collected by reviewing the medical records of patients with type 2 diabetes and add-on therapies at the time of presenting to endocrinologist according to clinical practice. The patients will participate in only one study visit, at the time of enrolment. Two study groups are to be defined at two time-points.
Read the detailed description
A non-interventional, multicenter study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. The study will enrol a minimum of 500 patients in each time point, resulting in a total of at least 1000 from approximately 50 investigators from Bulgaria. Each investigator will recruit approximately 10 subjects.
The assignment of the patients to a particular add-on therapy is not decided in advance by the NIS protocol, but falls within current practice and the prescription of medicine is clearly separated from the decision to include the subject in the study. No additional diagnostic and monitoring procedures shall be applied to patients, other than daily clinical practice and the epidemiological methods shall be used for the analysis of collected data. The intention of the study is to collect data on patients with type 2 diabetes and add-on therapies under routine clinical care.
The patients will participate in only one study visit, at the time of enrolment, when they provide the written informed consent, thus allowing the access to their data. Data will be collected by reviewing the medical records of patients.
Two study groups are to be defined at each time-point - one study group enrolled in moment 1 of evaluation (Feb - Mar 2015) and one study group enrolled in moment 2 of evaluation (Feb - Mar 2016). A patient enrolled in study moment 1 may not be enrolled in study moment 2. No patient will be prospectively followed-up during the study.
Investigators participating in this non-interventional study will be diabetologists in outpatient settings, as this group of specialists treats most of the T2DM patients in Bulgaria.
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes, add-on diabetes therapy, rationale
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patient group in moment 1 of evaluation | Study group enrolled in moment 1 of evaluation (Feb - Mar 2015) | |
| Patient group in moment 2 of evaluation | Study group enrolled in moment 2 of evaluation (Feb - Mar 2016) - 1 year distance from moment 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the frequency of usage by physicians of the main criteria for selecting the add-on therapy in patients with inadequately metformin-controlled type 2 diabetes
To describe and compare the main criteria used by physicians (regular outpatient setting) in selecting the add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Descriptive analysis will be produced for the response to questions stratified by patients (binominal variable) and within physician clusters (derived percentages). To describe the overall changes descriptive analysis will be used for those physician who have responses both in 2 time points at 1 year distance.
Measured: From moment 1 (up to 2 months from FSI) to moment 2 (1 year after moment 1)
Secondary outcomes (6)
Number of years (duration) of add-on therapies in type 2 diabetes
To describe the usage of add-on therapies in type 2 diabets and changes observed in 1 year. Descriptive analysis will be used within physician cluster for those physicians who have responses both in 2 time points at 1 year distance.
Measured: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Percentage of subjects with specific comorbid conditions and/or diabetes complications
To evaluate the prevalence of comorbidities and diabetes complications in study groups. Descriptive analysis will be produced within physician cluster.
Measured: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Percentage of patients with target HbA1c level < 7% at the 2 time-points
To evaluate the percentage if patients with target HbA1c level < 7% at the 2 time-points, by assessment of their last available HbA1c value. Descriptive analysis will be produced within physician cluster.
Measured: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Number of years of type 2 diabetes disease duration
To describe the characteristics of the disease at the time of initiating the add-on therapy in Bulgarian patients with type 2 diabetes. Descriptive analysis will be produced within physician cluster.
Measured: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Frequency of the used classes of drugs
To describe the usage of add-on therapies in type 2 diabets and changes observed in 1 year. Descriptive analysis will be used within physician cluster for those physicians who have responses both in 2 time points at 1 year distance.
Measured: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Number of years until starting the add-on therapies after diagnosis
To describe the characteristics of the disease at the time of initiating the add-on therapy in Bulgarian patients with type 2 diabetes. Descriptive analysis will be produced within physician cluster.
Measured: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study start2 Apr 2015
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
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
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Staneva, Study director, AstraZeneca Bulgaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355145
- Sponsor's protocol ID
- D1843R00243
- Acronym
- REALITY
- Status last verified
- May 2017
- First submitted
- 16 Jan 2015
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REALITY: A Non-inteRvEntional Study to Observe the rAtionaLe of selectIng add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin in Real-life Practice at 1 Year Distance
- ClinicalTrials.gov ID
- NCT02355145
- Acronym / sponsor ID
- REALITY / D1843R00243
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes, add-on diabetes therapy, rationale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2015 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 4 Feb 2015 (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.
A non-interventional, multicentre study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Data will be collected by reviewing the medical records of patients with type 2 diabetes and add-on therapies at the time of presenting to endocrinologist according to clinical practice. The patients will participate in only one study visit, at the time of enrolment. Two study groups are to be defined at two time-points.
Detailed description
A non-interventional, multicenter study to observe the main criteria used in clinical practice by physicians when selecting the second-line add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. The study will enrol a minimum of 500 patients in each time point, resulting in a total of at least 1000 from approximately 50 investigators from Bulgaria. Each investigator will recruit approximately 10 subjects.
The assignment of the patients to a particular add-on therapy is not decided in advance by the NIS protocol, but falls within current practice and the prescription of medicine is clearly separated from the decision to include the subject in the study. No additional diagnostic and monitoring procedures shall be applied to patients, other than daily clinical practice and the epidemiological methods shall be used for the analysis of collected data. The intention of the study is to collect data on patients with type 2 diabetes and add-on therapies under routine clinical care.
The patients will participate in only one study visit, at the time of enrolment, when they provide the written informed consent, thus allowing the access to their data. Data will be collected by reviewing the medical records of patients.
Two study groups are to be defined at each time-point - one study group enrolled in moment 1 of evaluation (Feb - Mar 2015) and one study group enrolled in moment 2 of evaluation (Feb - Mar 2016). A patient enrolled in study moment 1 may not be enrolled in study moment 2. No patient will be prospectively followed-up during the study.
Investigators participating in this non-interventional study will be diabetologists in outpatient settings, as this group of specialists treats most of the T2DM patients in Bulgaria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group in moment 1 of evaluation | – | –Study group enrolled in moment 1 of evaluation (Feb - Mar 2015) |
| Patient group in moment 2 of evaluation | – | –Study group enrolled in moment 2 of evaluation (Feb - Mar 2016) - 1 year distance from moment 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes patients, inadequately controlled with metformin, with a current treatment based on any add-on (non-insulin) diabetes therapy.
Key inclusion criteria (4 listed)
- Provision of subject informed consent
- Female and/or male aged 18 years and over
- Diagnosis of type 2 diabetes mellitus
- Patients considered inadequately controlled with metformin with a current treatment based on any add-on diabetes therapy
Key exclusion criteria (5 listed)
- Diagnosis of type 1 diabetes
- Current antidiabetes treatment with oral monotherapy
- Insulin treatment for type 2 diabetes
- Current participation in any clinical trial
- Patient who have been enrolled in the study at point 1 can not be enrolled at point 2
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
Change in the frequency of usage by physicians of the main criteria for selecting the add-on therapy in patients with inadequately metformin-controlled type 2 diabetes
Time frame: From moment 1 (up to 2 months from FSI) to moment 2 (1 year after moment 1)
To describe and compare the main criteria used by physicians (regular outpatient setting) in selecting the add-on therapy in patients with inadequately metformin-controlled type 2 diabetes in 2 time points at 1 year distance. Descriptive analysis will be produced for the response to questions stratified by patients (binominal variable) and within physician clusters (derived percentages). To describe the overall changes descriptive analysis will be used for those physician who have responses both in 2 time points at 1 year distance.
6 secondary outcomes
Number of years (duration) of add-on therapies in type 2 diabetes
Time frame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Percentage of subjects with specific comorbid conditions and/or diabetes complications
Time frame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Percentage of patients with target HbA1c level < 7% at the 2 time-points
Time frame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Number of years of type 2 diabetes disease duration
Time frame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Frequency of the used classes of drugs
Time frame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Number of years until starting the add-on therapies after diagnosis
Time frame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
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 30 May 2017.
- CSR SynopsisLink 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.
Marina Staneva study director
AstraZeneca Bulgaria
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 Bulgaria.
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 4 inclusion and 5 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 30 May 2017. 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 Bulgaria. 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?
Change in the frequency of usage by physicians of the main criteria for selecting the add-on therapy in patients with inadequately metformin-controlled type 2 diabetes (time frame: From moment 1 (up to 2 months from FSI) to moment 2 (1 year after moment 1)). 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 30 May 2017.