Clinical trial NCT02355145: Non-inteRvEntional Study to Observe rAtionaLe to Select add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes, add-on diabetes therapy, rationale
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-02-04
Enrollment: 1005
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes patients, inadequately controlled with metformin, with a current treatment based on any add-on (non-insulin) diabetes therapy.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
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
timeFrame: From moment 1 (up to 2 months from FSI) to moment 2 (1 year after moment 1)
Secondary outcomes:
measure: Number of years (duration) of add-on therapies in type 2 diabetes
timeFrame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
measure: Percentage of subjects with specific comorbid conditions and/or diabetes complications
timeFrame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
measure: Percentage of patients with target HbA1c level < 7% at the 2 time-points
timeFrame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
measure: Number of years of type 2 diabetes disease duration
timeFrame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
measure: Frequency of the used classes of drugs
timeFrame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
measure: Number of years until starting the add-on therapies after diagnosis
timeFrame: in 2 time points at 1 year distance - moment 1 (up to 2 months from FSI) and moment 2 (1 year after moment 1)
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
Study officials:
affiliation: AstraZeneca Bulgaria
name: Marina Staneva
role: STUDY_DIRECTOR
References: