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

Type 2 Diabetes Mellitus Clinical Trial

— DAPA-TURK  

Official title:

Dapagliflozin in Type 2 Diabetes Patients in Routine Internal Medicine and Endocrinology Outpatient Clinical Care; a Retrospective Cohort Study From Turkey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03407196
• Other study ID #: AZTRMT 2017-02
• Status: Completed
• Phase: N/A
• First received: December 4, 2017
• Last updated: March 6, 2018
• Start date: May 24, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: March 2018
• Source: AstraZeneca Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1683
• Est. completion date: February 28, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Forxiga
Oral antidiabetics

Locations

Country	Name	City	State
Turkey	Keçiören Training and Research Hospital	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca Turkey	Optimum Contract Research Organization, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from baseline in Total body weight [ Time Frame: 6 Months ]	The mean changes from mean baselines and at Month 6 in Total body weight.	6 months
Secondary	Changes from baseline in BMI [ Time Frame: 6 Months ]	The mean changes from mean baselines and at Month 6 in BMI	6 months
Secondary	Changes from baseline in Systolic Blood Pressures	The mean changes from mean baselines and at Month 6 in Systolic Blood Pressures	6 months
Secondary	Changes from baseline in Diastolic Blood Pressures [ Time Frame: 6 Months ]	The mean changes from mean baselines and at Month 6 in Diastolic Blood Pressures	6 months
Secondary	Discontinuation rates of dapagliflozin in the first 6 months of treatment	Discontinuation rates of dapagliflozin in the first 6 months of treatment	6 months