Clinical trial NCT03407196: Dapagliflozin in Type 2 Diabetes Patients, a Retrospective Cohort Study From Turkey
Official title: Dapagliflozin in Type 2 Diabetes Patients in Routine Internal Medicine and Endocrinology Outpatient Clinical Care; a Retrospective Cohort Study From Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Dapagliflozin
Endocrinology
Internal diseases
Type II diabetes mellitus
HbA1c
BMI
BP
Lead sponsor: AstraZeneca Turkey
Sponsor class: INDUSTRY
Collaborators: name: Optimum Contract Research Organization, Turkey
First posted: 2018-01-23
Enrollment: 1683
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort will be selected from patient records of 81 different centres. 1500 patients are planned to include in this study.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in HbA1c(%)
timeFrame: 6 months
Secondary outcomes:
measure: Changes from baseline in Total body weight [ Time Frame: 6 Months ]
timeFrame: 6 months
measure: Changes from baseline in BMI [ Time Frame: 6 Months ]
timeFrame: 6 months
measure: Changes from baseline in Systolic Blood Pressures
timeFrame: 6 months
measure: Changes from baseline in Diastolic Blood Pressures [ Time Frame: 6 Months ]
timeFrame: 6 months
measure: Discontinuation rates of dapagliflozin in the first 6 months of treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Keçiören Training and Research Hospital
Study officials:
affiliation: Diyarbakır Gazi Yaşargil T&R Hospital
name: Süleyman Özçaylak, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keçiören T&R Hospital
name: Kürşat Dal, Assc.ProfDr
role: PRINCIPAL_INVESTIGATOR
affiliation: Tepecik T&R Hospital
name: Muhammed Mu Demirpençe, Spec. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsun Medicana Hospital
name: Erdal Kan, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kocaeli Derince T&R Hospital
name: Tuğba Arkan, Spec. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uludag University
name: Canan Ersoy, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Gaziantep
name: Mustafa Araz, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Adana Başkent University
name: Okan Bakıner, Assc.ProfDr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin Tarsus State Hospital
name: Ramazan Kaya, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mustafa Kemal University
name: Eren Gürkan, Ast.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Manisa Private Grand Hospital
name: Hayati Ayakta, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Edirne State Hospital
name: Pınar Sırmatel, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Private İzan Hospital
name: Berna Da Ekiz, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Firat University
name: Faruk Kılınç, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inönü University
name: İbrahim Şahin, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Van 100.Yıl University
name: Rıfkı Üçler, Asc.Prof.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Semin M Fenkçi, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyon State Hospital
name: Mustafa Aydemir, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sivas Medicana Hospital
name: Emre Çiçekli, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yenimahalle T&R Hospital
name: Şahin Doğanay, Spec.Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Adana City Hospital
name: Özgür Keşkek, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medeniyet University
name: Aytekin Oğuz, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Kerem Sezer, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kayseri T&R Hospital
name: Oğuzhan S Dizdar, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Menemen State Hospital
name: Yasin Kocaöz, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Cerrahpaşa Medical Faculty
name: Mahir Cengiz, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara T&R Hospital
name: Nilgün G Gıynaş, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bozyaka T&R Hospital
name: Hakan Doğan, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bağcılar T&R Hospital
name: Erdal Gündoğan, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gölbaşı State Hospital
name: Çağlar Köseoğlu, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulus State Hospital
name: Rıfat Bozkuş, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bornova Türkan Özilhan State Hospital
name: Murat Medeni, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eskişehir Private Anadolu Hospital
name: Mehmet Çelebioğlu, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Düzce State Hospital
name: Mustafa Çalışkan, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bursa Yüksek İhtisas T&R Hospital
name: Metin Güçlü, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziantep T&R Hospital
name: Özcan Özbağ, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bülent Ecevit University
name: Taner Bayraktaroğlu, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kanuni Sultan Süleyman T&R Hospital
name: Ömür Tabak, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Emirdağ State Hospital
name: Erhan Bozkurt, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Merzifon State Hospital
name: Selçuk Sezikli, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Çanakkale State Hospital
name: Ersen Karakılıç, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Uskudar State Hospital
name: Ayça S Erdem, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin City State Hospital
name: Deniz Gezer, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hatay Akademi Hospital
name: Nuh Baklacı, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Manisa State Hospital
name: Sabriye Ö Kafesçiler, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Namik Kemal University
name: Sayid S Zuhur, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Fethiye State Hospital
name: Göktürk Kılınç, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Elazığ T&R Hospital
name: Mustafa Timurkağan, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gaziantep Medicalpark Hospital
name: Ümit Çınkır, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Denizli Private Tekden Hospital
name: Semra Tursun, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyon Kocatepe University
name: Memnune S Ulu, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokat State Hospital
name: Çiğdem B Tuna, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Atatürk State Hospital
name: Harun Aysal, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: TC Erciyes University
name: Züleyha Karaca, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: İstanbul Eyüp State Hospital
name: Murat Akbaş, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Adana Aşkım Tüfekçi State Hospital
name: Ahmet Z Şahin, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Şişli Etfal T&R Hospital
name: Esra Çil Şen, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya T&R Hospital
name: Mehmet Çelik, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya T&R Hospital
name: Metin Sarıkaya, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ümraniye T&R Hospital
name: Hacı Bayram, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dicle University
name: Alparslan K Tuzcu, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Keçiören T&R Hospital
name: Derun T Ertuğrul, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: İlhan Yetkin, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Diyarbakır Gazi Yaşargil T&R Hospital
name: Mehmet Çoşkun, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: T.C. Dumlupınar Üniversitesi
name: Kevser Onbaşı, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Harran University
name: Mehmet A Eren, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara University
name: Rıfat Emral, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mersin University
name: Ramazan Gen, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Haseki T&R Hospital
name: Esra Ataoğlu, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: Barış Akıncı, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University
name: Ramazan Sarı, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Adana Başkent University
name: Emre Bozkırlı, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Istanbul Medical Faculty
name: Kubilay Karşıdağ, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Çukurova University
name: Tamer Tetiker, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Selçuk University
name: Levent Kebapçılar, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakırköy Dr.Sadi Konuk T&R Hospital
name: Yıldız Okuturlar, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. Nazif Bağrıaçık Kadıköy Hospital
name: Enver Şükrü Göncüoğlu, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eskişehir Yunus Emre State Hospital
name: Bengür Taşkıran, Spec.Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Trabzon Medicalpark Hospital
name: İnan Anaforoğlu, Asc.Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
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