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Trial record 14 of 7511 for:    Type 2 Diabetes

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

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ClinicalTrials.gov Identifier: NCT02355145
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Type 2 Diabetes Mellitus

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

Study Type : Observational
Actual Enrollment : 1005 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : April 2, 2015
Primary Completion Date : July 28, 2016
Study Completion Date : July 28, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    To evaluate the prevalence of comorbidities and diabetes complications in study groups. Descriptive analysis will be produced within physician cluster.

  3. 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) ]
    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.

  4. 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) ]
    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.

  5. 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) ]
    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.

  6. 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) ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355145


Locations
Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Stara Zagora, Bulgaria
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Marina Staneva AstraZeneca Bulgaria
More Information

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02355145     History of Changes
Other Study ID Numbers: D1843R00243
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by AstraZeneca:
type 2 diabetes, add-on diabetes therapy, rationale

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs