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

NCT03407196 | Completed

• 1 other identifier: AZTRMT 2017-02
• Study Type: observational
• Target: 1,683
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; Dapagliflozin; Endocrinology; Internal diseases; Type II diabetes mellitus; HbA1c; BMI; BP

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Changes from baseline in Total body weight [ Time Frame: 6 Months ]

  6 months

• Changes from baseline in BMI [ Time Frame: 6 Months ]

  6 months

• Changes from baseline in Systolic Blood Pressures

  6 months

• Changes from baseline in Diastolic Blood Pressures [ Time Frame: 6 Months ]

  6 months

• Discontinuation rates of dapagliflozin in the first 6 months of treatment

  6 months

Interventions

Forxiga DRUG

Oral antidiabetics

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca Turkey: lead
• Optimum Contract Research Organization, Turkey: collaborator

Study Sites (1)

Keçiören Training and Research Hospital

Ankara, 06280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Süleyman Özçaylak, Spec.Dr.

  Diyarbakır Gazi Yaşargil T&R Hospital

  PRINCIPAL INVESTIGATOR

• Kürşat Dal, Assc.ProfDr

  Keçiören T&R Hospital

  PRINCIPAL INVESTIGATOR

• Muhammed Mu Demirpençe, Spec. Dr.

  Tepecik T&R Hospital

  PRINCIPAL INVESTIGATOR

• Erdal Kan, Spec.Dr.

  Samsun Medicana Hospital

  PRINCIPAL INVESTIGATOR

• Tuğba Arkan, Spec. Dr.

  Kocaeli Derince T&R Hospital

  PRINCIPAL INVESTIGATOR

• Canan Ersoy, Prof.Dr.

  Uludag University

  PRINCIPAL INVESTIGATOR

• Mustafa Araz, Prof.Dr.

  University of Gaziantep

  PRINCIPAL INVESTIGATOR

• Okan Bakıner, Assc.ProfDr

  Adana Başkent University

  PRINCIPAL INVESTIGATOR

• Ramazan Kaya, Spec.Dr.

  Mersin Tarsus State Hospital

  PRINCIPAL INVESTIGATOR

• Eren Gürkan, Ast.Prof.Dr.

  Mustafa Kemal University

  PRINCIPAL INVESTIGATOR

• Hayati Ayakta, Spec.Dr.

  Manisa Private Grand Hospital

  PRINCIPAL INVESTIGATOR

• Pınar Sırmatel, Spec.Dr.

  Edirne State Hospital

  PRINCIPAL INVESTIGATOR

• Berna Da Ekiz, Spec.Dr.

  Muğla Private İzan Hospital

  PRINCIPAL INVESTIGATOR

• Faruk Kılınç, Spec.Dr.

  Firat University

  PRINCIPAL INVESTIGATOR

• İbrahim Şahin, Prof.Dr.

  Inönü University

  PRINCIPAL INVESTIGATOR

• Rıfkı Üçler, Asc.Prof.Dr

  Van 100.Yıl University

  PRINCIPAL INVESTIGATOR

• Semin M Fenkçi, Prof.Dr.

  Pamukkale University

  PRINCIPAL INVESTIGATOR

• Mustafa Aydemir, Spec.Dr.

  Afyon State Hospital

  PRINCIPAL INVESTIGATOR

• Emre Çiçekli, Spec.Dr.

  Sivas Medicana Hospital

  PRINCIPAL INVESTIGATOR

• Şahin Doğanay, Spec.Dr

  Yenimahalle T&R Hospital

  PRINCIPAL INVESTIGATOR

• Özgür Keşkek, Asc.Prof.Dr.

  Adana City Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Aytekin Oğuz, Prof.Dr.

  Medeniyet University

  PRINCIPAL INVESTIGATOR

• Kerem Sezer, Prof.Dr.

  Mersin University

  PRINCIPAL INVESTIGATOR

• Oğuzhan S Dizdar, Spec.Dr.

  Kayseri T&R Hospital

  PRINCIPAL INVESTIGATOR

• Yasin Kocaöz, Spec.Dr.

  Menemen State Hospital

  PRINCIPAL INVESTIGATOR

• Mahir Cengiz, Spec.Dr.

  Istanbul University Cerrahpaşa Medical Faculty

  PRINCIPAL INVESTIGATOR

• Nilgün G Gıynaş, Spec.Dr.

  Ankara T&R Hospital

  PRINCIPAL INVESTIGATOR

• Hakan Doğan, Spec.Dr.

  Bozyaka T&R Hospital

  PRINCIPAL INVESTIGATOR

• Erdal Gündoğan, Spec.Dr.

  Bağcılar T&R Hospital

  PRINCIPAL INVESTIGATOR

• Çağlar Köseoğlu, Spec.Dr.

  Gölbaşı State Hospital

  PRINCIPAL INVESTIGATOR

• Rıfat Bozkuş, Spec.Dr.

  Ulus State Hospital

  PRINCIPAL INVESTIGATOR

• Murat Medeni, Spec.Dr.

  Bornova Türkan Özilhan State Hospital

  PRINCIPAL INVESTIGATOR

• Mehmet Çelebioğlu, Spec.Dr.

  Eskişehir Private Anadolu Hospital

  PRINCIPAL INVESTIGATOR

• Mustafa Çalışkan, Spec.Dr.

  Düzce State Hospital

  PRINCIPAL INVESTIGATOR

• Metin Güçlü, Asc.Prof.Dr.

  Bursa Yüksek İhtisas T&R Hospital

  PRINCIPAL INVESTIGATOR

• Özcan Özbağ, Spec.Dr.

  Gaziantep T&R Hospital

  PRINCIPAL INVESTIGATOR

• Taner Bayraktaroğlu, Prof.Dr.

  Bülent Ecevit University

  PRINCIPAL INVESTIGATOR

• Ömür Tabak, Asc.Prof.Dr.

  Kanuni Sultan Süleyman T&R Hospital

  PRINCIPAL INVESTIGATOR

• Erhan Bozkurt, Spec.Dr.

  Emirdağ State Hospital

  PRINCIPAL INVESTIGATOR

• Selçuk Sezikli, Spec.Dr.

  Merzifon State Hospital

  PRINCIPAL INVESTIGATOR

• Ersen Karakılıç, Spec.Dr.

  Çanakkale State Hospital

  PRINCIPAL INVESTIGATOR

• Ayça S Erdem, Spec.Dr.

  Uskudar State Hospital

  PRINCIPAL INVESTIGATOR

• Deniz Gezer, Spec.Dr.

  Mersin City State Hospital

  PRINCIPAL INVESTIGATOR

• Nuh Baklacı, Spec.Dr.

  Hatay Akademi Hospital

  PRINCIPAL INVESTIGATOR

• Sabriye Ö Kafesçiler, Spec.Dr.

  Manisa State Hospital

  PRINCIPAL INVESTIGATOR

• Sayid S Zuhur, Asc.Prof.Dr.

  Namik Kemal University

  PRINCIPAL INVESTIGATOR

• Göktürk Kılınç, Spec.Dr.

  Fethiye State Hospital

  PRINCIPAL INVESTIGATOR

• Mustafa Timurkağan, Spec.Dr.

  Elazığ T&R Hospital

  PRINCIPAL INVESTIGATOR

• Ümit Çınkır, Spec.Dr.

  Gaziantep Medicalpark Hospital

  PRINCIPAL INVESTIGATOR

• Semra Tursun, Spec.Dr.

  Denizli Private Tekden Hospital

  PRINCIPAL INVESTIGATOR

• Memnune S Ulu, Asc.Prof.Dr.

  Afyon Kocatepe University

  PRINCIPAL INVESTIGATOR

• Çiğdem B Tuna, Spec.Dr.

  Tokat State Hospital

  PRINCIPAL INVESTIGATOR

• Harun Aysal, Spec.Dr.

  Antalya Atatürk State Hospital

  PRINCIPAL INVESTIGATOR

• Züleyha Karaca, Asc.Prof.Dr.

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

• Murat Akbaş, Spec.Dr.

  İstanbul Eyüp State Hospital

  PRINCIPAL INVESTIGATOR

• Ahmet Z Şahin, Spec.Dr.

  Adana Aşkım Tüfekçi State Hospital

  PRINCIPAL INVESTIGATOR

• Esra Çil Şen, Spec.Dr.

  Şişli Etfal T&R Hospital

  PRINCIPAL INVESTIGATOR

• Mehmet Çelik, Spec.Dr.

  Antalya T&R Hospital

  PRINCIPAL INVESTIGATOR

• Metin Sarıkaya, Spec.Dr.

  Antalya T&R Hospital

  PRINCIPAL INVESTIGATOR

• Hacı Bayram, Spec.Dr.

  Ümraniye T&R Hospital

  PRINCIPAL INVESTIGATOR

• Alparslan K Tuzcu, Prof.Dr.

  Dicle University

  PRINCIPAL INVESTIGATOR

• Derun T Ertuğrul, Asc.Prof.Dr.

  Keçiören T&R Hospital

  PRINCIPAL INVESTIGATOR

• İlhan Yetkin, Prof.Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Mehmet Çoşkun, Spec.Dr.

  Diyarbakır Gazi Yaşargil T&R Hospital

  PRINCIPAL INVESTIGATOR

• Kevser Onbaşı, Prof.Dr.

  T.C. Dumlupınar Üniversitesi

  PRINCIPAL INVESTIGATOR

• Mehmet A Eren, Asc.Prof.Dr.

  Harran University

  PRINCIPAL INVESTIGATOR

• Rıfat Emral, Prof.Dr.

  Ankara University

  PRINCIPAL INVESTIGATOR

• Ramazan Gen, Asc.Prof.Dr.

  Mersin University

  PRINCIPAL INVESTIGATOR

• Esra Ataoğlu, Asc.Prof.Dr.

  Haseki T&R Hospital

  PRINCIPAL INVESTIGATOR

• Barış Akıncı, Prof.Dr.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Ramazan Sarı, Prof.Dr.

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• Emre Bozkırlı, Asc.Prof.Dr.

  Adana Başkent University

  PRINCIPAL INVESTIGATOR

• Kubilay Karşıdağ, Prof.Dr.

  Istanbul University Istanbul Medical Faculty

  PRINCIPAL INVESTIGATOR

• Tamer Tetiker, Prof.Dr.

  Cukurova University

  PRINCIPAL INVESTIGATOR

• Levent Kebapçılar, Prof.Dr.

  Selcuk University

  PRINCIPAL INVESTIGATOR

• Yıldız Okuturlar, Asc.Prof.Dr.

  Bakırköy Dr.Sadi Konuk T&R Hospital

  PRINCIPAL INVESTIGATOR

• Enver Şükrü Göncüoğlu, Spec.Dr.

  Dr. Nazif Bağrıaçık Kadıköy Hospital

  PRINCIPAL INVESTIGATOR

• Bengür Taşkıran, Spec.Dr.

  Eskişehir Yunus Emre State Hospital

  PRINCIPAL INVESTIGATOR

• İnan Anaforoğlu, Asc.Prof.Dr.

  Trabzon Medicalpark Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: January 23, 2018
• Study Start: May 24, 2017
• Primary Completion: December 31, 2017
• Study Completion: February 28, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

TU (1)