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Multicenter Study to Demonstrate the Effects of Sotaglifozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Cardiovascular risk Factors and Moderately Impaired Renal Function
Turkey (TurkMSIC) - Dumlupinar University, Kutahya
Kutahya Health Sciences University, Cardiology Department, Evliya Celebi Campus, Tavsanlı Road 10. Km, 43100, Kutahya/Merkez
Associated Prof. Taner Sen
Associated Prof. Taner Sen Associated Prof. Mehmet Ali Astarcioglu
Type of Research Project
- Basic science
What is the background of the project?
Recent data indicate that sodium-glucose linked transporter 2 (SGLT2) inhibitors may address the growing unmet medical need of treatment for prevention of CV (cardiovascular) death and HF (Heart Failure) and progression of renal impairment in patients with type 2 DM (Diabetes Mellitus). SGLT2 may affect volume status via sodium and volume reduction and or a decrease in arterial pressure. The possible diuresis and beneficial effects on maladaptive renal arteriolar responses may have led to improvement in both systolic and diastolic function, thereby lowering HF hospitalization and sudden cardiac death. Sotaglifozin, a potent dual inhibitor of SGLT2 and SGLT1. Therefore, based on its effect on plasma volume and renal hemodynamics, hemodynamics, chronic treatment with sotaglifozin is expected to both reduce the CV risk and the progression of DKD (Diabetic Kidney Disease) in patients with type 2 DM.
What is the aim of the project?
One of the primary objective is the sotaglifozin reduce the composite endpoint of cardiovascular death death of heart failure hospitalization when compared to placebo in patients with type 2 diabetes mellitus , cardiovascular risk factors and moderately impaired renal function.
What techniques and methods are used?
this study is a Phase 3 , multicebter and multinationalirandomized double blind placebo controlled parallel group study in approximately 10500 patients with type 2 DM ,CV risk factors and moderately impaired renal function. This study will consists of 3 periods. 1. A screening period of 1 to 4 weeks 2. A randomized double blind treatment period including up titration (the dose of sotaglifozin or matched placebo should be increased from 200 mg to 400 mg in the first 6 months of randomized double blind treatment period if tolerated 3. A 14 day post treatment period
What is the role of the student?
- The student will mainly observe
- The tasks will be done under supervision
What are the tasks expected to be accomplished by the student?
The student will observe or perform under supervision the following tasks: Keeping the records patient vitals (pulse, telemetry, blood pressure) after examinations of study participants. Ms Excel and SPSS 26 programs. (Statistical Package for Social Sciences) Occasionally observing the patient-doctor interactions during examinations of study participants. Keeping the record of endocrinological (Hemoglobin A1C, random plasma glucose) cardiological values of study participants (Left ventricular ejection fraction, heart rate, cardiothroacic ratio on x-ray, ankle edema rating) The specifics regarding the treatments of the study participants are detailed in the ‘’techniques and methods’’ part. The student will not be involved in the follow ups, they will only be involved in the 2. Stage (titration of treatment in a 6 month period).
Will there be any theoretical teaching provided (preliminary readings, lectures, courses, seminars etc)
The following topics will be provided in the form of seminars by Associated Prof. Mehmet Ali Astarcioglu. Lessons will be provided according to the availability of the teacher, at least once per week. Introduction to cardiovascular disease Introduction to diabetes mellitus pathophysiology Antidiabetic medication and SGLT2 inhibitors Phases of pharmaceutical trials
What is expected from the student at the end of the research exchange? What will be the general outcome of the student?
- The student will prepare a scientific report
What skills are required of the student? Is there any special knowledge or a certain level of studies needed?
No specific skills are required.
Are there any legal limitations in the student’s involvement
Type of students accepted
This project accepts: - Medical students
- Zinman B; Lachin JM; Inzucchi SE.Empagliflozin; Cardiovascular Outcomes; and Mortality in Type 2 Diabetes.N Engl J Med. 2016 Mar 17;374(11): 1094. doi: 10.1056/NEJMc1600827.
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