Non-inteRvEntional Study to Observe rAtionaLe to Select add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin. (REALITY)

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT02355145

D1843R00243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,005 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,005 participants in 2 patient groups

Patient group in moment 1 of evaluation

Description:

Study group enrolled in moment 1 of evaluation (Feb - Mar 2015)

Patient group in moment 2 of evaluation

Description:

Study group enrolled in moment 2 of evaluation (Feb - Mar 2016) - 1 year distance from moment 1