Non-inteRvEntional Study to Observe rAtionaLe to Select add-on TherapY for Type 2 Diabetes Inadequately Controlled With Metformin.
NCT ID: NCT02355145
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1005 participants
OBSERVATIONAL
2015-04-02
2016-07-28
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient group in moment 1 of evaluation
Study group enrolled in moment 1 of evaluation (Feb - Mar 2015)
No interventions assigned to this group
Patient group in moment 2 of evaluation
Study group enrolled in moment 2 of evaluation (Feb - Mar 2016) - 1 year distance from moment 1
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Marina Staneva
Role: STUDY_DIRECTOR
AstraZeneca Bulgaria
Locations
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Research Site
Pleven, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Stara Zagora, , Bulgaria
Countries
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Related Links
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Other Identifiers
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D1843R00243
Identifier Type: -
Identifier Source: org_study_id
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