N/A
Completed N=1,502
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
Source: ClinicalTrials.gov NCT03764631 ↗Enrolled (actual)
1,502
Serious AEs
0.5%
Results posted
Feb 2022
Primary outcomePrimary: Number of Participants With Ketoacidosis — 1; 1 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ketoacidosis |
1; 1 | — |
| PRIMARY Number of Participants With Severe Urinary Tract Infections (UTIs) |
0; 0 | — |
| PRIMARY Number of Participants With Volume Depletion |
6; 7 | — |
| PRIMARY Number of Participants With Dehydration |
0; 0 | — |
| SECONDARY Number of Participants With Ketoacidosis During Ramadan Periods |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Severe Urinary Tract Infections (UTIs) During Ramadan Periods |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Volume Depletion During Ramadan Periods |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Dehydration During Ramadan Periods |
0; 0; 0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03764631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.