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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin cohort | Patients diagnosed with type 2 diabetes that started dapagliflozin treatment at least 6 months before the beginning of the study. |
| |
| Sitagliptin cohort | Patients diagnosed with type 2 diabetes that started sitagliptin treatment at least 6 months before the beginning of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Evaluation of the effectiveness and safety of the Dapagliflozin treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months +/- 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months +/- 3 months |
| Evaluate the security of the treatment |
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Inclusion Criteria:
5. The patient must sign the informed consent to participate in the study.
Exclusion Criteria:
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Patients over 18 years old with stable DM2 with antihyperglycaemic therapy, being included in their treatment dapagliflozin or sitagliptin medication.
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| Name | Affiliation | Role |
|---|---|---|
| Cristobal Morales Portillo | Hospital Universitario Virgen Macarena | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cristóbal Morales Portillo | Seville | Andalusia | 41009 | Spain |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sitagliptin | Drug | Evaluation of the effectiveness and safety of the Sitagliptin treatment. |
|
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Study of the incidence of the urinary and genital infections as well as the hypoglycemia incidence and its severity. |
| 6 months +/- 3 months |
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |