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

Retrospective and Multicenter 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Dapagliflozin; Drug: Sitagliptin

• Study Type: Observational
• Enrollment (Actual): 1080

Contacts and Locations

Study Locations

• Spain
  • Andalucía
    • Sevilla, Andalucía, Spain, 41009
      • Cristóbal Morales Portillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dapagliflozin cohort; Patients diagnosed with type 2 diabetes that started dapagliflozin treatment at least 6 months before the beginning of the study.	Drug: Dapagliflozin; Evaluation of the effectiveness and safety of the Dapagliflozin treatment.; Other Names: iSGLT2
Sitagliptin cohort; Patients diagnosed with type 2 diabetes that started sitagliptin treatment at least 6 months before the beginning of the study.	Drug: Sitagliptin; Evaluation of the effectiveness and safety of the Sitagliptin treatment.; Other Names: iDPP4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Collaborators: AstraZeneca
• Investigators: Study Director: Cristobal Morales Portillo, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 5, 2017
• Primary Completion (ACTUAL): March 15, 2019
• Study Completion (ACTUAL): March 15, 2019

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (ACTUAL): November 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Sodium-Glucose Transporter 2 Inhibitors; Dipeptidyl-Peptidase IV Inhibitors; Dapagliflozin; Sitagliptin Phosphate
• Other Study ID Numbers: FIS-DAP-2016-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No