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

Sponsor
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study ID
NCT04149067
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Evaluation of the effectiveness and safety of the Dapagliflozin treatment.
  • Sitagliptin — DRUG
    Evaluation of the effectiveness and safety of the Sitagliptin treatment.

Study Details

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.

Key Dates

Start date
Jun 5, 2017
Status verified
May 2019
Primary completion
Mar 15, 2019
Completion
Mar 15, 2019

Study Design

Enrollment
1,080 participants (actual)

Arms

  • Arm: Dapagliflozin cohort
    Patients diagnosed with type 2 diabetes that started dapagliflozin treatment at least 6 months before the beginning of the study.
  • Arm: Sitagliptin cohort
    Patients diagnosed with type 2 diabetes that started sitagliptin treatment at least 6 months before the beginning of the study.

Primary Outcome Measure

0.5% in Hb1Ac and 1.5 kg in body weight [ Time Frame: 6 months +/- 3 months ]

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