At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,502 enrolled
Drug / intervention
Empagliflozin +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating Empagliflozin and Dipeptidyl-peptidase 4 (DPP-4) inhibitors for Diabetes Mellitus, Type 2. Completed, enrolled 1,502 participants across 21 sites.
Detailed 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
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesSaudi Arabia
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartSep 2018
First PostedDec 2018
Primary CompletionJan 2021
TodayJul 2026
First PostedDec 5, 2018
Enrollment StartSep 26, 2018
Primary CompletionJan 11, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.6 years ago
Interventions
Empagliflozindrug
Drug
Dipeptidyl-peptidase 4 (DPP-4) inhibitorsdrug
Dipeptidyl-peptidase 4 - Drug