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

NCT04149067 | Completed

• 1 other identifier: FIS-DAP-2016-01
• Study Type: observational
• Target: 1,080
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluate the results due to the use of SGLT2i/DPP4i

  6 months +/- 3 months

• Evaluate the security of the treatment

  6 months +/- 3 months

Study Arms (2)

Dapagliflozin cohort

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

Drug: Dapagliflozin

Sitagliptin cohort

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

Drug: Sitagliptin

Interventions

Dapagliflozin DRUG

Evaluation of the effectiveness and safety of the Dapagliflozin treatment.

Also known as: iSGLT2

Dapagliflozin cohort

Sitagliptin DRUG

Evaluation of the effectiveness and safety of the Sitagliptin treatment.

Also known as: iDPP4

Sitagliptin cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old with stable DM2 with antihyperglycaemic therapy, being included in their treatment dapagliflozin or sitagliptin medication.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead
• AstraZeneca: collaborator

Study Sites (1)

Cristóbal Morales Portillo

Seville, Andalusia, 41009, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Cristobal Morales Portillo

  Hospital Universitario Virgen Macarena

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: November 4, 2019
• Study Start: June 5, 2017
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-05

Locations

ES (1)