An observational study in Type 2 Diabetes Mellitus, sponsored by AstraZeneca Turkey. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-07.
Sponsored by AstraZeneca Turkey (part of AstraZeneca) · Observational
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Among 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca — 13 open to participants now, 15 under way, 9 of them phase 3. Diabetes Mellitus, Type 2 · AstraZeneca.
Among the 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca, this one is the 39th largest by enrollment of the 65 observational ones that give a count, is one of 22 that started in 2017, is one of 65 observational ones, and was the 294th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →13 of the 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in United States, Argentina, Brazil and 8 more countries
Ages 18+
AstraZeneca · Sites in China, Hong Kong, Malaysia and 2 more countries
Ages 18+
AstraZeneca · Sites in United States, Argentina, Australia and 13 more countries
Ages 18+
AstraZeneca · Sites in United States
Ages 18–55 · Healthy volunteers
AstraZeneca · Sites in United States, Australia, Bulgaria and 10 more countries
Ages 18+
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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345 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 89 · Phase 2 47 · Phase 3 122 · Phase 4 28
First in 2001; this study’s year is marked. 22 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,683 is above the median of 300 across 1,742 observational studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 155 across the 280 interventional studies, 2,000 across the 65 observational. Of the 325 that completed or were terminated, 149 (46%) have results posted.
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This study is registered under AstraZeneca Turkey, one of the names counted as AstraZeneca. Under that name alone:
AstraZeneca Turkey is the lead sponsor of 3 studies on the registry; none are open to participants now.
5 of the studies in Diabetes Mellitus, Type 2 by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07723833AstraZenecaA Study to Investigate the Relative Bioavailability and Safety of Different Oral Formulations of Elecoglipron in Healthy Participants | 2026-11-18 |
| NCT07534592AstraZenecaA Study to Investigate the Effect of Elecoglipron on Rosuvastatin and Atorvastatin in Healthy Participants | 2027-01-25 |
| NCT07024823AstraZenecaA Study to Investigate Safety, Tolerability, PK, and PD of AZD4248 in Healthy Participants, Participants With CKD and Type 2 Diabetes, Assess Home Measurements of Creatinine in a Non-Interventional Cohort, and Assess the Effect of AZD4248 on the PK of Midazolam and Metformin in Healthy Participants | 2027-01-29 |
| NCT06151964AstraZenecaA Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight | 2027-01-29 |
| NCT07606066AstraZenecaA Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies | 2027-03-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 345 studies in Diabetes Mellitus, Type 2 by AstraZeneca, from their registry updates:
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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.
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.
The study cohort will be selected from patient records of 81 different centres. 1500 patients are planned to include in this study.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral antidiabetics
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.
Time frame: 6 months
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.
Time frame: 6 months
Changes from baseline in BMI [ Time Frame: 6 Months ]
The mean changes from mean baselines and at Month 6 in BMI
Time frame: 6 months
Changes from baseline in Systolic Blood Pressures
The mean changes from mean baselines and at Month 6 in Systolic Blood Pressures
Time frame: 6 months
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
Time frame: 6 months
Discontinuation rates of dapagliflozin in the first 6 months of treatment
Discontinuation rates of dapagliflozin in the first 6 months of treatment
Time frame: 6 months
Ran from May 2017 to primary completion in Dec 2017, 7 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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