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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149067
• Other study ID #: FIS-DAP-2016-01
• Status: Completed
• Start date: June 5, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: May 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1080
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin
Evaluation of the effectiveness and safety of the Dapagliflozin treatment.
• Sitagliptin
Evaluation of the effectiveness and safety of the Sitagliptin treatment.

Locations

Country	Name	City	State
Spain	Cristóbal Morales Portillo	Sevilla	Andalucía

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Evaluate the security of the treatment	Study of the incidence of the urinary and genital infections as well as the hypoglycemia incidence and its severity.	6 months +/- 3 months