Dapagliflozin in Type 2 Diabetes Patients, a Retrospective Cohort Study From Turkey

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 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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

DRUG

Forxiga

Oral antidiabetics

Sponsors & Collaborators

• Optimum Contract Research Organization, Turkey

  collaborator UNKNOWN

• AstraZeneca Turkey

  lead INDUSTRY

Principal Investigators

• Süleyman Özçaylak, Spec.Dr. · Diyarbakır Gazi Yaşargil T&R Hospital

• Kürşat Dal, Assc.ProfDr · Keçiören T&R Hospital

• Muhammed Mu Demirpençe, Spec. Dr. · Tepecik T&R Hospital

• Erdal Kan, Spec.Dr. · Samsun Medicana Hospital

• Tuğba Arkan, Spec. Dr. · Kocaeli Derince T&R Hospital

• Canan Ersoy, Prof.Dr. · Uludag University

• Mustafa Araz, Prof.Dr. · University of Gaziantep

• Okan Bakıner, Assc.ProfDr · Adana Başkent University

• Ramazan Kaya, Spec.Dr. · Mersin Tarsus State Hospital

• Eren Gürkan, Ast.Prof.Dr. · Mustafa Kemal University

• Hayati Ayakta, Spec.Dr. · Manisa Private Grand Hospital

• Pınar Sırmatel, Spec.Dr. · Edirne State Hospital

• Berna Da Ekiz, Spec.Dr. · Muğla Private İzan Hospital

• Faruk Kılınç, Spec.Dr. · Firat University

• İbrahim Şahin, Prof.Dr. · Inönü University

• Rıfkı Üçler, Asc.Prof.Dr · Van 100.Yıl University

• Semin M Fenkçi, Prof.Dr. · Pamukkale University

• Mustafa Aydemir, Spec.Dr. · Afyon State Hospital

• Emre Çiçekli, Spec.Dr. · Sivas Medicana Hospital

• Şahin Doğanay, Spec.Dr · Yenimahalle T&R Hospital

• Özgür Keşkek, Asc.Prof.Dr. · Adana City Hospital

• Aytekin Oğuz, Prof.Dr. · Medeniyet University

• Kerem Sezer, Prof.Dr. · Mersin University

• Oğuzhan S Dizdar, Spec.Dr. · Kayseri T&R Hospital

• Yasin Kocaöz, Spec.Dr. · Menemen State Hospital

• Mahir Cengiz, Spec.Dr. · Istanbul University Cerrahpaşa Medical Faculty

• Nilgün G Gıynaş, Spec.Dr. · Ankara T&R Hospital

• Hakan Doğan, Spec.Dr. · Bozyaka T&R Hospital

• Erdal Gündoğan, Spec.Dr. · Bağcılar T&R Hospital

• Çağlar Köseoğlu, Spec.Dr. · Gölbaşı State Hospital

• Rıfat Bozkuş, Spec.Dr. · Ulus State Hospital

• Murat Medeni, Spec.Dr. · Bornova Türkan Özilhan State Hospital

• Mehmet Çelebioğlu, Spec.Dr. · Eskişehir Private Anadolu Hospital

• Mustafa Çalışkan, Spec.Dr. · Düzce State Hospital

• Metin Güçlü, Asc.Prof.Dr. · Bursa Yüksek İhtisas T&R Hospital

• Özcan Özbağ, Spec.Dr. · Gaziantep T&R Hospital

• Taner Bayraktaroğlu, Prof.Dr. · Bülent Ecevit University

• Ömür Tabak, Asc.Prof.Dr. · Kanuni Sultan Süleyman T&R Hospital

• Erhan Bozkurt, Spec.Dr. · Emirdağ State Hospital

• Selçuk Sezikli, Spec.Dr. · Merzifon State Hospital

• Ersen Karakılıç, Spec.Dr. · Çanakkale State Hospital

• Ayça S Erdem, Spec.Dr. · Uskudar State Hospital

• Deniz Gezer, Spec.Dr. · Mersin City State Hospital

• Nuh Baklacı, Spec.Dr. · Hatay Akademi Hospital

• Sabriye Ö Kafesçiler, Spec.Dr. · Manisa State Hospital

• Sayid S Zuhur, Asc.Prof.Dr. · Namik Kemal University

• Göktürk Kılınç, Spec.Dr. · Fethiye State Hospital

• Mustafa Timurkağan, Spec.Dr. · Elazığ T&R Hospital

• Ümit Çınkır, Spec.Dr. · Gaziantep Medicalpark Hospital

• Semra Tursun, Spec.Dr. · Denizli Private Tekden Hospital

• Memnune S Ulu, Asc.Prof.Dr. · Afyon Kocatepe University

• Çiğdem B Tuna, Spec.Dr. · Tokat State Hospital

• Harun Aysal, Spec.Dr. · Antalya Atatürk State Hospital

• Züleyha Karaca, Asc.Prof.Dr. · TC Erciyes University

• Murat Akbaş, Spec.Dr. · İstanbul Eyüp State Hospital

• Ahmet Z Şahin, Spec.Dr. · Adana Aşkım Tüfekçi State Hospital

• Esra Çil Şen, Spec.Dr. · Şişli Etfal T&R Hospital

• Mehmet Çelik, Spec.Dr. · Antalya T&R Hospital

• Metin Sarıkaya, Spec.Dr. · Antalya T&R Hospital

• Hacı Bayram, Spec.Dr. · Ümraniye T&R Hospital

• Alparslan K Tuzcu, Prof.Dr. · Dicle University

• Derun T Ertuğrul, Asc.Prof.Dr. · Keçiören T&R Hospital

• İlhan Yetkin, Prof.Dr. · Gazi University

• Mehmet Çoşkun, Spec.Dr. · Diyarbakır Gazi Yaşargil T&R Hospital

• Kevser Onbaşı, Prof.Dr. · T.C. Dumlupınar Üniversitesi

• Mehmet A Eren, Asc.Prof.Dr. · Harran University

• Rıfat Emral, Prof.Dr. · Ankara University

• Ramazan Gen, Asc.Prof.Dr. · Mersin University

• Esra Ataoğlu, Asc.Prof.Dr. · Haseki T&R Hospital

• Barış Akıncı, Prof.Dr. · Dokuz Eylul University

• Ramazan Sarı, Prof.Dr. · Akdeniz University

• Emre Bozkırlı, Asc.Prof.Dr. · Adana Başkent University

• Kubilay Karşıdağ, Prof.Dr. · Istanbul University Istanbul Medical Faculty

• Tamer Tetiker, Prof.Dr. · Cukurova University

• Levent Kebapçılar, Prof.Dr. · Selçuk University

• Yıldız Okuturlar, Asc.Prof.Dr. · Bakırköy Dr.Sadi Konuk T&R Hospital

• Enver Şükrü Göncüoğlu, Spec.Dr. · Dr. Nazif Bağrıaçık Kadıköy Hospital

• Bengür Taşkıran, Spec.Dr. · Eskişehir Yunus Emre State Hospital

• İnan Anaforoğlu, Asc.Prof.Dr. · Trabzon Medicalpark Hospital

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-24

Primary Completion

2017-12-31

Completion

2018-02-28

Countries

• Turkey (Türkiye)

Study Locations