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

Sponsor
Boehringer Ingelheim
Study ID
NCT03764631
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
    Drug
  • Dipeptidyl-peptidase 4 (DPP-4) inhibitors — DRUG
    Dipeptidyl-peptidase 4 - Drug

Study Details

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

Key Dates

Start date
Sep 26, 2018
Status verified
Feb 2022
Primary completion
Jan 11, 2021
Completion
Jan 11, 2021

Study Design

Enrollment
1,502 participants (actual)

Arms

  • Arm: subjects with Type 2 Diabetes mellitus

Primary Outcome Measure

Number of Participants With Ketoacidosis [ Time Frame: Up to 12 months after the index date (defined as the date on which each identified new user received the index prescription for Empagliflozin or DPP-4 inhibitor). ]

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