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

Launched by BOEHRINGER INGELHEIM · Dec 4, 2018

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Eligibility criteria

• 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.