Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
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 compar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 26 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 11 2021
Estimated Enrollment :
1502 Patients enrolled
Trial Details
Trial ID
NCT03764631
Start Date
September 26 2018
End Date
January 11 2021
Last Update
February 10 2022
Active Locations (21)
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1
Abha International Private Hospital
Abhā, Saudi Arabia, 61431
2
DAFA Special Polyclinic
Jeddah, Saudi Arabia, 21214
3
Ghassan Najeeb Pharaon Hospital
Jeddah, Saudi Arabia, 21412
4
International Medical Center
Jeddah, Saudi Arabia, 21451