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

NCT ID: NCT04149067

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1080 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-05
• Study Completion Date: 2019-03-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dapagliflozin cohort

Patients diagnosed with type 2 diabetes that started dapagliflozin treatment at least 6 months before the beginning of the study.

Dapagliflozin

Intervention Type: DRUG

Evaluation of the effectiveness and safety of the Dapagliflozin treatment.

Sitagliptin cohort

Patients diagnosed with type 2 diabetes that started sitagliptin treatment at least 6 months before the beginning of the study.

Sitagliptin

Intervention Type: DRUG

Evaluation of the effectiveness and safety of the Sitagliptin treatment.

Interventions

Dapagliflozin

Evaluation of the effectiveness and safety of the Dapagliflozin treatment.

Intervention Type: DRUG

Sitagliptin

Evaluation of the effectiveness and safety of the Sitagliptin treatment.

Intervention Type: DRUG

Other Intervention Names

iSGLT2; iDPP4

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with T2DM.

2. Age: 18-75 years.

3. Treatment with dapagliflozin or sitagliptin that started at least 6 months before the recruitment date.

4. 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.

5. 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).

5. The patient must sign the informed consent to participate in the study.

Exclusion Criteria

1. Impediment of the patient to give him informed consent.

2. Patients diagnosed with Type 1 Diabetes.

3. Women with gestational diabetes.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cristobal Morales Portillo

Role: STUDY_DIRECTOR

Hospital Universitario Virgen Macarena

Locations

Cristóbal Morales Portillo

Seville, Andalusia, Spain

Countries

Spain

Other Identifiers

FIS-DAP-2016-01

Identifier Type: -

Identifier Source: org_study_id