NCT04149067

Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain

Retrospective and Multicenter Study of Real-world Evidence With SGLT2i (Dapagliflozin) and DPP4i (Sitagliptin) in Type 2 Diabetes Patients in Spain

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,080 (actual)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Evaluation of the effectiveness and safety of the Dapagliflozin treatment.
DRUG	Sitagliptin	Evaluation of the effectiveness and safety of the Sitagliptin treatment.

Timeline

• Start date: 2017-06-05
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2019-11-04
• Last updated: 2019-11-04

Locations

1 site across 1 country: Spain