NCT03764631

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

Post-authorization Safety Study in Patients With Type 2 Diabetes Mellitus to Assess the Incidence of Ketoacidosis, Severe Complications of Urinary Tract Infection, Volume Depletion, and Dehydration Among Patients Treated With Empagliflozin or DPP-4 Inhibitors in Saudi Arabia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,502 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 compared to patient initiating a dipeptidyl peptidase-4 (DPP-4) inhibitors over a 12-month period of follow-up, including the month of Ramadan

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Empagliflozin	Drug
DRUG	Dipeptidyl-peptidase 4 (DPP-4) inhibitors	Dipeptidyl-peptidase 4 - Drug

Timeline

• Start date: 2018-09-26
• Primary completion: 2021-01-11
• Completion: 2021-01-11
• First posted: 2018-12-05
• Last updated: 2022-02-10
• Results posted: 2022-02-10

Locations

21 sites across 1 country: Saudi Arabia

Regulatory

• FDA-regulated drug study