Post-authorization Safety Study in Type 2 Diabetic Patients in Saudi Arabia Treated With Empagliflozin to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration

Boehringer Ingelheim

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Dipeptidyl-peptidase 4 (DPP-4) inhibitors

Drug: Empagliflozin

Study type

Observational

Funder types

Industry

Identifiers

NCT03764631

1245-0149

Details and patient eligibility

About

The objectives of this study are to assess the risk of ketoacidosis, severe urinary tract infections, volume depletion, and dehydration associated in patients with T2DM initiating Empagliflozin compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over a 12-month period of follow-up, including the month of Ramadan

Enrollment

1,502 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who have signed Informed consent form.
The patients will be at least 18 years old at index date, diagnosed with Type 2 diabetes mellitus (T2DM) in Saudi Arabia, and who will initiate Empagliflozin or Dipeptidyl-peptidase 4 (DPP4) inhibitors treatment according to the local label and at the discretion of the treating physician during the study period, who have not used other sodium/glucose co-transporter 2 (SGLT2) or DPP4 inhibitors during the previous 12 months.

Exclusion criteria

Known hypersensitivity to Empagliflozin, the comparator DPP-4 inhibitors or any of their excipients
Patients for whom Empagliflozin or the comparator DPP-4 inhibitor is contraindicated according Saudi Food and Drug Authority (SFDA) approved label
Patients prescribed fixed-dose combinations of SGLT2 inhibitors with DPP-4 inhibitors will be excluded.
The same inclusion and exclusion criteria will be applied to the comparator group, which will include new users of DPP-4 inhibitors.