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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

NCT03764631 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1502

Last updated 2022-02-10

Study results available
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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

DRUG

Empagliflozin

Drug

DRUG

Dipeptidyl-peptidase 4 (DPP-4) inhibitors

Dipeptidyl-peptidase 4 - Drug

Sponsors & Collaborators

Principal Investigators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2021-01-11
Completion
2021-01-11
FDA Drug
Yes

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764631 on ClinicalTrials.gov