Type 2 Diabetes MellitusDAPA-TURKNCT03407196
Dapagliflozin in Type 2 Diabetes Patients, a Retrospective Cohort Study From Turkey
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca Turkey at 1 site in Turkey (Türkiye).
Trial summary
Background/Rationale: Objectives and Hypotheses: To describe characteristics of patients with type 2 diabetes (T2D) prescribed dapagliflozin in routine internal medicine and endocrinology outpatient clinical care in Turkey; to describe changes in HbA1c(%), weight(kg), BMI(kg/m^2) and blood pressure (BP)(mmHg) in these… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Forxiga
- Type of treatment
- Pill or oral medicine
- How many people
- 1,683 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2017to 28 Feb 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort will be selected from patient records of 81 different centres. 1500 patients are planned to include in this study.
Who may be able to join
- Age ≥18 and ≤75 years at index date.
- First prescription for dapagliflozin between July 2016 and Aug 2017
- Minimum 6 months of registration in the centres at the index date
- Established Type 2 diabetes prior to the index date
Who cannot join
- Patients with Type 1 diabetes
- Patients with gestational diabetes
- Being included in another interventional clinical trial at between index date and enrollment date
- Estimated Glomerular Filtration Rate < 30 ml/min
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Keçiören Training and Research Hospital
Ankara, 06280
About this study
Official title: Dapagliflozin in Type 2 Diabetes Patients in Routine Internal Medicine and Endocrinology Outpatient Clinical Care; a Retrospective Cohort Study From Turkey
Background/Rationale:
Objectives and Hypotheses: To describe characteristics of patients with type 2 diabetes (T2D) prescribed dapagliflozin in routine internal medicine and endocrinology outpatient clinical care in Turkey; to describe changes in HbA1c(%), weight(kg), BMI(kg/m^2) and blood pressure (BP)(mmHg) in these patients; and the discontinuation rates of dapagliflozin in the first 6 months of treatment.
Read more
Methods:
Study design: a retrospective observational cohort study. Data Source(s): Patient medical records of 81 different centres. Study Population: patients with a diagnosis of T2D, a first prescription for dapagliflozin, between July 2016 and Aug 2017 and who have been registered in the participating centre at least 6 months prior to first prescription of dapagliflozin.
Study variables: patient characteristics: age, gender, smoking status, co-morbidities, duration of diabetes, prescribed medicines, HbA1c(%), weight(kg), body mass index (BMI)(kg/m^2) and blood pressure (BP)(mmHg).
Outcome(s): description of patient characteristics, HbA1c(%), weight(kg), BMI(kg/m^2) and BP(mmHg) at baseline and during use of dapagliflozin at first visit (2,3 or 4 months) and second visit (5 or 6 months).
Sample Size Estimations:1500 patients Statistical Analysis: the baseline characteristics and follow up variables will be described using frequency and percentage distributions for categorical variables. Continuous and count variables will be described using mean (± standard deviation), median (quartiles) and 95% confidence intervals. Proportion of patients falling above/below certain weight(kg)/BMI(kg/m^2), HbA1c(%) and BP(mmHg) thresholds will be derived. HbA1c(%), weight(kg), BMI(kg/m^2) and BP(mmHg) will be described at baseline and during use of dapagliflozin. Over all questionnaire response rate and rate of response to reasons for prescribing dapagliflozin will be described.
Limitations: Variation in timing and completeness of clinical measures. The patient medical records are not collected for research purposes and the diagnostic and procedure coding on such data may be recorded incorrectly or not recorded at all, thereby potentially introducing measurement error with respect to code-based variables. The centres participating in the study, record that a prescription was issued, but not whether it was dispensed from the pharmacy.
Read the detailed description
This study is a descriptive retrospective observational cohort study using data from Turkish patient medical records from 81 different internal medicine and/or endocrinology clinics across the whole country.
The study cohort will include T2D patients who received at least one prescription for dapagliflozin for the first time between July 2016 and Aug 2017 and who have been registered in that centre for at least 6 months prior to the first dapagliflozin prescription.
The selection of sites and investigators will be made with an aim to achieve representativeness of the way dapagliflozin treated T2D patients are managed across Turkey. The National Coordinator will provide advice regarding the proportion of the different types of centres (Internal medicine, endocrinology clinics, different types of hospitals, geographical distribution) and investigators (different types of specialists) involved in dapagliflozin treated T2D patient management. The National Coordinator will also provide insight on the national situation regarding dapagliflozin medication prescription (reimbursement, public or private insurance). All this information will be used to select sites and investigators for the study, resembling as closely as possible, the real-world situation.
Sites will also be evaluated for existence and use of electronic medical records as part of feasibility. Data quality of sites will be assessed before initiation visit. The study centre database should provide at least 20 patients to the study. In case the study centre, can provide more than 20 patients, then patients will be selected randomly by the Contract Research Organization. Contract Research Organization will also record total number of eligible patients, their age and sex details before performing randomization. The randomization process will be performed at the study site after initiation visit by Contract Research Organization. The investigator of the centre will enter only selected patients to study Case Report Form. The Contract Research Organization will also perform 100% source document verification following completion of Case Report Forms by the investigator. All centres will be evaluated by Contract Research Organization at initiation visit in terms of data quality (Baseline, first visit and second visit data of eligible patients)
The date of the first prescription for dapagliflozin in patient medical records is the index date. Patients will be followed from the index date until the earliest of transfer out date, death date or end date of patient records (last date of data collection). Required data mentioned in baseline characteristics (section 5.1) will be recorded at index date, first visit (2 or 3 or 4 months after index date) and second visit (5 or 6 months after index date) of treatment (section 5.2).
Dataset quality will be assessed by Contract Research Organization at initiation visit. Site investigator is responsible for entering data to Case Report Forms. Paper based Case Report Form system will be used for this study. Datasets can differ for each hospital and patient's records can be electronic and/or printed. The investigator will collect all necessary data for each patient retrospectively from the most reliable data source in the clinic. All collected data will be verified by the Contract Research Organization.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Forxiga
- Keywords
- Diabetes, Dapagliflozin, Endocrinology, Internal diseases, Type II diabetes mellitus, HbA1c, BMI, BP
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForxigaDrug
Oral antidiabetics
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c(%)
To record the mean change in HbA1C from baseline [ Time Frame: 6 Months ] Changes over time (6 months) in HbA1c(%) value in these patients.
Measured: 6 months
Secondary outcomes (5)
Changes from baseline in Total body weight [ Time Frame: 6 Months ]
The mean changes from mean baselines and at Month 6 in Total body weight.
Measured: 6 months
Changes from baseline in BMI [ Time Frame: 6 Months ]
The mean changes from mean baselines and at Month 6 in BMI
Measured: 6 months
Changes from baseline in Systolic Blood Pressures
The mean changes from mean baselines and at Month 6 in Systolic Blood Pressures
Measured: 6 months
Changes from baseline in Diastolic Blood Pressures [ Time Frame: 6 Months ]
The mean changes from mean baselines and at Month 6 in Diastolic Blood Pressures
Measured: 6 months
Discontinuation rates of dapagliflozin in the first 6 months of treatment
Discontinuation rates of dapagliflozin in the first 6 months of treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start24 May 2017
- Primary completion31 Dec 2017
- Study completion28 Feb 2018
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.
- 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
- Retrospective
- Enrolment
- 1,683 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca Turkey
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optimum Contract Research Organization, Turkey
- Responsible party
- Sponsor
- Investigators
- Süleyman Özçaylak, Spec.Dr., Principal investigator, Diyarbakır Gazi Yaşargil T&R HospitalKürşat Dal, Assc.ProfDr, Principal investigator, Keçiören T&R HospitalMuhammed Mu Demirpençe, Spec. Dr., Principal investigator, Tepecik T&R HospitalErdal Kan, Spec.Dr., Principal investigator, Samsun Medicana HospitalTuğba Arkan, Spec. Dr., Principal investigator, Kocaeli Derince T&R HospitalCanan Ersoy, Prof.Dr., Principal investigator, Uludag UniversityMustafa Araz, Prof.Dr., Principal investigator, University of GaziantepOkan Bakıner, Assc.ProfDr, Principal investigator, Adana Başkent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407196
- Sponsor's protocol ID
- AZTRMT 2017-02
- Acronym
- DAPA-TURK
- Status last verified
- Mar 2018
- First submitted
- 4 Dec 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin in Type 2 Diabetes Patients in Routine Internal Medicine and Endocrinology Outpatient Clinical Care; a Retrospective Cohort Study From Turkey
- ClinicalTrials.gov ID
- NCT03407196
- Acronym / sponsor ID
- DAPA-TURK / AZTRMT 2017-02
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Dapagliflozin, Endocrinology, Internal diseases, Type II diabetes mellitus, HbA1c, BMI, BP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,683 participants (actual)
- Lead sponsor
- AstraZeneca TurkeyIndustry (pharma, biotech, devices)
- Collaborators
- Optimum Contract Research Organization, Turkey
- Study start
- 24 May 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
Background/Rationale:
Objectives and Hypotheses: To describe characteristics of patients with type 2 diabetes (T2D) prescribed dapagliflozin in routine internal medicine and endocrinology outpatient clinical care in Turkey; to describe changes in HbA1c(%), weight(kg), BMI(kg/m^2) and blood pressure (BP)(mmHg) in these patients; and the discontinuation rates of dapagliflozin in the first 6 months of treatment.
Methods:
Study design: a retrospective observational cohort study. Data Source(s): Patient medical records of 81 different centres. Study Population: patients with a diagnosis of T2D, a first prescription for dapagliflozin, between July 2016 and Aug 2017 and who have been registered in the participating centre at least 6 months prior to first prescription of dapagliflozin.
Study variables: patient characteristics: age, gender, smoking status, co-morbidities, duration of diabetes, prescribed medicines, HbA1c(%), weight(kg), body mass index (BMI)(kg/m^2) and blood pressure (BP)(mmHg).
Outcome(s): description of patient characteristics, HbA1c(%), weight(kg), BMI(kg/m^2) and BP(mmHg) at baseline and during use of dapagliflozin at first visit (2,3 or 4 months) and second visit (5 or 6 months).
Sample Size Estimations:1500 patients Statistical Analysis: the baseline characteristics and follow up variables will be described using frequency and percentage distributions for categorical variables. Continuous and count variables will be described using mean (± standard deviation), median (quartiles) and 95% confidence intervals. Proportion of patients falling above/below certain weight(kg)/BMI(kg/m^2), HbA1c(%) and BP(mmHg) thresholds will be derived. HbA1c(%), weight(kg), BMI(kg/m^2) and BP(mmHg) will be described at baseline and during use of dapagliflozin. Over all questionnaire response rate and rate of response to reasons for prescribing dapagliflozin will be described.
Limitations: Variation in timing and completeness of clinical measures. The patient medical records are not collected for research purposes and the diagnostic and procedure coding on such data may be recorded incorrectly or not recorded at all, thereby potentially introducing measurement error with respect to code-based variables. The centres participating in the study, record that a prescription was issued, but not whether it was dispensed from the pharmacy.
Detailed description
This study is a descriptive retrospective observational cohort study using data from Turkish patient medical records from 81 different internal medicine and/or endocrinology clinics across the whole country.
The study cohort will include T2D patients who received at least one prescription for dapagliflozin for the first time between July 2016 and Aug 2017 and who have been registered in that centre for at least 6 months prior to the first dapagliflozin prescription.
The selection of sites and investigators will be made with an aim to achieve representativeness of the way dapagliflozin treated T2D patients are managed across Turkey. The National Coordinator will provide advice regarding the proportion of the different types of centres (Internal medicine, endocrinology clinics, different types of hospitals, geographical distribution) and investigators (different types of specialists) involved in dapagliflozin treated T2D patient management. The National Coordinator will also provide insight on the national situation regarding dapagliflozin medication prescription (reimbursement, public or private insurance). All this information will be used to select sites and investigators for the study, resembling as closely as possible, the real-world situation.
Sites will also be evaluated for existence and use of electronic medical records as part of feasibility. Data quality of sites will be assessed before initiation visit. The study centre database should provide at least 20 patients to the study. In case the study centre, can provide more than 20 patients, then patients will be selected randomly by the Contract Research Organization. Contract Research Organization will also record total number of eligible patients, their age and sex details before performing randomization. The randomization process will be performed at the study site after initiation visit by Contract Research Organization. The investigator of the centre will enter only selected patients to study Case Report Form. The Contract Research Organization will also perform 100% source document verification following completion of Case Report Forms by the investigator. All centres will be evaluated by Contract Research Organization at initiation visit in terms of data quality (Baseline, first visit and second visit data of eligible patients)
The date of the first prescription for dapagliflozin in patient medical records is the index date. Patients will be followed from the index date until the earliest of transfer out date, death date or end date of patient records (last date of data collection). Required data mentioned in baseline characteristics (section 5.1) will be recorded at index date, first visit (2 or 3 or 4 months after index date) and second visit (5 or 6 months after index date) of treatment (section 5.2).
Dataset quality will be assessed by Contract Research Organization at initiation visit. Site investigator is responsible for entering data to Case Report Forms. Paper based Case Report Form system will be used for this study. Datasets can differ for each hospital and patient's records can be electronic and/or printed. The investigator will collect all necessary data for each patient retrospectively from the most reliable data source in the clinic. All collected data will be verified by the Contract Research Organization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will be selected from patient records of 81 different centres. 1500 patients are planned to include in this study.
Key inclusion criteria (4 listed)
- Age ≥18 and ≤75 years at index date.
- First prescription for dapagliflozin between July 2016 and Aug 2017
- Minimum 6 months of registration in the centres at the index date
- Established Type 2 diabetes prior to the index date
Key exclusion criteria (4 listed)
- Patients with Type 1 diabetes
- Patients with gestational diabetes
- Being included in another interventional clinical trial at between index date and enrollment date
- Estimated Glomerular Filtration Rate < 30 ml/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ForxigaOral antidiabetics | Drug | – |
Primary outcome
Change in HbA1c(%)
Time frame: 6 months
To record the mean change in HbA1C from baseline [ Time Frame: 6 Months ] Changes over time (6 months) in HbA1c(%) value in these patients.
5 secondary outcomes
Changes from baseline in Total body weight [ Time Frame: 6 Months ]
Time frame: 6 months
Changes from baseline in BMI [ Time Frame: 6 Months ]
Time frame: 6 months
Changes from baseline in Systolic Blood Pressures
Time frame: 6 months
Changes from baseline in Diastolic Blood Pressures [ Time Frame: 6 Months ]
Time frame: 6 months
Discontinuation rates of dapagliflozin in the first 6 months of treatment
Time frame: 6 months
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 7 Mar 2018.
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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.
Süleyman Özçaylak, Spec.Dr. principal investigator
Diyarbakır Gazi Yaşargil T&R Hospital
Kürşat Dal, Assc.ProfDr principal investigator
Keçiören T&R Hospital
Muhammed Mu Demirpençe, Spec. Dr. principal investigator
Tepecik T&R Hospital
1 site 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 Turkey at 1 site in Turkey (Türkiye).
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 4 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 HbA1c(%) (time frame: 6 months). 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 7 Mar 2018.