Dapagliflozin in Type 2 Diabetes Patients, a Retrospective Cohort Study From Turkey
NCT ID: NCT03407196
Last Updated: 2018-03-07
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1683 participants
OBSERVATIONAL
2017-05-24
2018-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dapagliflozin Effect on Erythropoiesis and Physical Fitness
NCT03423355
Dapagliflozin on Hyperlipidemia and Insulin Resistance in Type 2 Diabetic Patients (DAPHNIS Study)
NCT02577159
SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes
NCT06054035
Dapagliflozin, Cardio-Metabolic Risk Factors and Type-2 Diabetes
NCT03377335
A Study to to Assess the Effect of Dapagliflozin When Administered Once a Day Versus Twice a Day on Blood Glucose
NCT01072578
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Forxiga
Oral antidiabetics
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Optimum Contract Research Organization, Turkey
UNKNOWN
AstraZeneca Turkey
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Süleyman Özçaylak, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Diyarbakır Gazi Yaşargil T&R Hospital
Kürşat Dal, Assc.ProfDr
Role: PRINCIPAL_INVESTIGATOR
Keçiören T&R Hospital
Muhammed Mu Demirpençe, Spec. Dr.
Role: PRINCIPAL_INVESTIGATOR
Tepecik T&R Hospital
Erdal Kan, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Samsun Medicana Hospital
Tuğba Arkan, Spec. Dr.
Role: PRINCIPAL_INVESTIGATOR
Kocaeli Derince T&R Hospital
Canan Ersoy, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Uludag University
Mustafa Araz, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Gaziantep
Okan Bakıner, Assc.ProfDr
Role: PRINCIPAL_INVESTIGATOR
Adana Başkent University
Ramazan Kaya, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Mersin Tarsus State Hospital
Eren Gürkan, Ast.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Mustafa Kemal University
Hayati Ayakta, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Manisa Private Grand Hospital
Pınar Sırmatel, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Edirne State Hospital
Berna Da Ekiz, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Muğla Private İzan Hospital
Faruk Kılınç, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Firat University
İbrahim Şahin, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Inönü University
Rıfkı Üçler, Asc.Prof.Dr
Role: PRINCIPAL_INVESTIGATOR
Van 100.Yıl University
Semin M Fenkçi, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Pamukkale University
Mustafa Aydemir, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Afyon State Hospital
Emre Çiçekli, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Sivas Medicana Hospital
Şahin Doğanay, Spec.Dr
Role: PRINCIPAL_INVESTIGATOR
Yenimahalle T&R Hospital
Özgür Keşkek, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Adana City Hospital
Aytekin Oğuz, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Medeniyet University
Kerem Sezer, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Mersin University
Oğuzhan S Dizdar, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Kayseri T&R Hospital
Yasin Kocaöz, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Menemen State Hospital
Mahir Cengiz, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Istanbul University Cerrahpaşa Medical Faculty
Nilgün G Gıynaş, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Ankara T&R Hospital
Hakan Doğan, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Bozyaka T&R Hospital
Erdal Gündoğan, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Bağcılar T&R Hospital
Çağlar Köseoğlu, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Gölbaşı State Hospital
Rıfat Bozkuş, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Ulus State Hospital
Murat Medeni, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Bornova Türkan Özilhan State Hospital
Mehmet Çelebioğlu, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Eskişehir Private Anadolu Hospital
Mustafa Çalışkan, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Düzce State Hospital
Metin Güçlü, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Bursa Yüksek İhtisas T&R Hospital
Özcan Özbağ, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Gaziantep T&R Hospital
Taner Bayraktaroğlu, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Bülent Ecevit University
Ömür Tabak, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Kanuni Sultan Süleyman T&R Hospital
Erhan Bozkurt, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Emirdağ State Hospital
Selçuk Sezikli, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Merzifon State Hospital
Ersen Karakılıç, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Çanakkale State Hospital
Ayça S Erdem, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Uskudar State Hospital
Deniz Gezer, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Mersin City State Hospital
Nuh Baklacı, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Hatay Akademi Hospital
Sabriye Ö Kafesçiler, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Manisa State Hospital
Sayid S Zuhur, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Namik Kemal University
Göktürk Kılınç, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Fethiye State Hospital
Mustafa Timurkağan, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Elazığ T&R Hospital
Ümit Çınkır, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Gaziantep Medicalpark Hospital
Semra Tursun, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Denizli Private Tekden Hospital
Memnune S Ulu, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Afyon Kocatepe University
Çiğdem B Tuna, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Tokat State Hospital
Harun Aysal, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Antalya Atatürk State Hospital
Züleyha Karaca, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
TC Erciyes University
Murat Akbaş, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
İstanbul Eyüp State Hospital
Ahmet Z Şahin, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Adana Aşkım Tüfekçi State Hospital
Esra Çil Şen, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Şişli Etfal T&R Hospital
Mehmet Çelik, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Antalya T&R Hospital
Metin Sarıkaya, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Antalya T&R Hospital
Hacı Bayram, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Ümraniye T&R Hospital
Alparslan K Tuzcu, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Dicle University
Derun T Ertuğrul, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Keçiören T&R Hospital
İlhan Yetkin, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Gazi University
Mehmet Çoşkun, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Diyarbakır Gazi Yaşargil T&R Hospital
Kevser Onbaşı, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
T.C. Dumlupınar Üniversitesi
Mehmet A Eren, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Harran University
Rıfat Emral, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Ankara University
Ramazan Gen, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Mersin University
Esra Ataoğlu, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Haseki T&R Hospital
Barış Akıncı, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Dokuz Eylul University
Ramazan Sarı, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Akdeniz University
Emre Bozkırlı, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Adana Başkent University
Kubilay Karşıdağ, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Istanbul University Istanbul Medical Faculty
Tamer Tetiker, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Cukurova University
Levent Kebapçılar, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Selçuk University
Yıldız Okuturlar, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Bakırköy Dr.Sadi Konuk T&R Hospital
Enver Şükrü Göncüoğlu, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Dr. Nazif Bağrıaçık Kadıköy Hospital
Bengür Taşkıran, Spec.Dr.
Role: PRINCIPAL_INVESTIGATOR
Eskişehir Yunus Emre State Hospital
İnan Anaforoğlu, Asc.Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
Trabzon Medicalpark Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Keçiören Training and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AZTRMT 2017-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.