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Dapagliflozin in Type 2 Diabetes Patients, a Retrospective Cohort Study From Turkey (DAPA-TURK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03407196
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Optimum Contract Research Organization, Turkey
Information provided by (Responsible Party):
AstraZeneca Turkey

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.


Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Forxiga

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.

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Study Type : Observational
Actual Enrollment : 1683 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dapagliflozin in Type 2 Diabetes Patients in Routine Internal Medicine and Endocrinology Outpatient Clinical Care; a Retrospective Cohort Study From Turkey
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Forxiga
    Oral antidiabetics


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes from baseline in Total body weight [ Time Frame: 6 Months ] [ Time Frame: 6 months ]
    The mean changes from mean baselines and at Month 6 in Total body weight.

  2. Changes from baseline in BMI [ Time Frame: 6 Months ] [ Time Frame: 6 months ]
    The mean changes from mean baselines and at Month 6 in BMI

  3. Changes from baseline in Systolic Blood Pressures [ Time Frame: 6 months ]
    The mean changes from mean baselines and at Month 6 in Systolic Blood Pressures

  4. Changes from baseline in Diastolic Blood Pressures [ Time Frame: 6 Months ] [ Time Frame: 6 months ]
    The mean changes from mean baselines and at Month 6 in Diastolic Blood Pressures

  5. Discontinuation rates of dapagliflozin in the first 6 months of treatment [ Time Frame: 6 months ]
    Discontinuation rates of dapagliflozin in the first 6 months of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03407196


Locations
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Turkey
Keçiören Training and Research Hospital
Ankara, Turkey, 06280
Sponsors and Collaborators
AstraZeneca Turkey
Optimum Contract Research Organization, Turkey
Investigators
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Principal Investigator: 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 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. Üsküdar 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. Çukurova University
Principal Investigator: Levent Kebapçılar, Prof.Dr. Selçuk 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
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Responsible Party: AstraZeneca Turkey
ClinicalTrials.gov Identifier: NCT03407196    
Other Study ID Numbers: AZTRMT 2017-02
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca Turkey:
Diabetes
Dapagliflozin
Endocrinology
Internal diseases
Type II diabetes mellitus
HbA1c
BMI
BP
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs