The aim of this study is to develop a retrospective, multicenter and observational study in Spain in real clinical practice to assess the employment of dapagliflozin and to compare its effectiveness and safety with the data of sitagliptin, a DPP4 inhibitor. This is a widely used molecule in Spain with a large safety profile. It was chosen as a comparator because of the number of patients treated and because it is a real alternative at the time of making a decision about the treatment.
Study Type
OBSERVATIONAL
Enrollment
1,080
Evaluation of the effectiveness and safety of the Dapagliflozin treatment.
Evaluation of the effectiveness and safety of the Sitagliptin treatment.
Cristóbal Morales Portillo
Seville, Andalusia, Spain
0.5% in Hb1Ac and 1.5 kg in body weight
The aim of the study is to assess the effectiveness of the SGLT2i (dapagliflozin) and DPP4i (Sitagliptin) over the composite endpoint of Hb1Ac and weight at six month of treatment. The main variable is composite, including Hb1Ac and body weight. It will be evaluated the proportion of patient to achieve a change of 0.5% in Hb1Ac and 1.5 kg in body weight. It was chosen sitagliptin because the researchers involved in this study have much experience with this molecule with a large number of patients already treated.
Time frame: 6 months +/- 3 months
Evaluate the results due to the use of SGLT2i/DPP4i
Assessment of the SGLT2i/DPP4i use in single, double or triple therapy and analysis of the baseline features of the patients at the beginning and at the end of the treatment, including the concomitant medication.
Time frame: 6 months +/- 3 months
Evaluate the security of the treatment
Study of the incidence of the urinary and genital infections as well as the hypoglycemia incidence and its severity.
Time frame: 6 months +/- 3 months
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