Complications of UTI in Patients on Dapagliflozin

Completed

Conditions studied: Severe Complications of Urinary Tract Infections

In brief

The objective of this study is to compare, by insulin use at the index date, the sex-specific incidence of hospitalization or emergency department (ED) visit for severe complications of urinary tract infections (UTI), defined as pyelonephritis and urosepsis, among patients with type 2 diabetes mellitus (T2DM) who are new users of dapagliflozin with those who are new users of antidiabetic drugs (ADs) in classes other than sodium-glucose cotransporter 2 (SGLT2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.

Key facts

Study ID

NCT02695173

Run by

AstraZeneca

People needed

683380

Starts

2017-01-01

Expected to finish

2020-11-30

Last updated by the study team

2021-12-07

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years and older (CPRD and HIRD), or 65 years or older (Medicare);
• no diagnosisi of type 1 diabetes,
• are new users of one of the study drugs and
• have at least 180 days of electronic data before their first prescription of the study drug

You may not qualify if…

• The patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time).
• The patient was prescribed an SGLT2 inhibitor other than dapagliflozin on or before the index date.
• The patient initiated metformin or sulfonylurea as AD monotherapy at the index date.
• The patient initiated insulin therapy at the index date.
• The patient had evidence of type 1 diabetes before cohort entry or first recorded AD is insulin monotherapy

Where it is running

• Research Site — Wilmington, Delaware, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.