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Completed

NCT Number: NCT04149067

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

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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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cristóbal Morales Portillo

Seville, Andalusia, 41009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with T2DM.
  • Age: 18-75 years.
  • Treatment with dapagliflozin or sitagliptin that started at least 6 months before the recruitment date.
  • The patient must have at least two follow-up visits. The basal initial visit, where all the relevant information is collected and a second follow-up visit.
  • The next information of the subjects should be available at the recruitment of the basal visit: Sex, age (years), date of diagnosis of T2DM, weight, height, systolic and diastolic blood pressure, body mass index (BMI: kg / m2), concomitant medication (antiHTA, statins, aspirin, etc.), glucose basal fasting (mg / dL), HbA1c (%) and estimated GFR by CKD-EPI (mL / min / 1.73m2).
  • The patient must sign the informed consent to participate in the study.

Exclusion criteria

  • Impediment of the patient to give him informed consent.
  • Patients diagnosed with Type 1 Diabetes.
  • Women with gestational diabetes.

Treatment and study plan

Dapagliflozin

Drug

Evaluation of the effectiveness and safety of the Dapagliflozin treatment.

Other names: iSGLT2

Sitagliptin

Drug

Evaluation of the effectiveness and safety of the Sitagliptin treatment.

Other names: iDPP4

Primary outcomes

  1. 0.5% in Hb1Ac and 1.5 kg in body weight

    Time frame: 6 months +/- 3 months

    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.

Secondary outcomes

  1. Evaluate the results due to the use of SGLT2i/DPP4i

    Time frame: 6 months +/- 3 months

    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.

  2. Evaluate the security of the treatment

    Time frame: 6 months +/- 3 months

    Study of the incidence of the urinary and genital infections as well as the hypoglycemia incidence and its severity.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 4, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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