Clinical trial NCT02695173: Complications of UTI in Patients on Dapagliflozin
Official title: Comparison of the Risk of Severe Complications of Urinary Tract Infections Between Patients With Type 2 Diabetes Exposed to Dapafliglozin and Those Exposed to Other Antidiabetic Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Complications of Urinary Tract Infections
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 683380
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of antidiabetic drugs in classes other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy. Up to four comparator subjects will be matched to each dapagliozin user.

Brief summary: 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.

Detailed description: The overall goal of this research study is to estimate the sex-specific incidence of hospitalization or emergency department visit for severe complications of urinary tract infections, defined as pyelonephritis and urosepsis, in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. Dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations.

The study will be implemented in three administrative health care data sources in two countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD); and in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the HealthCore Integrated Research Database (HIRDSM). Individuals in the databases will be included in the study if they meet the following age criteria; 18 years and older (CPRD and HIRD), or 65 years or older (Medicare); and if they did not have type 1 diabetes, are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. The study period starts July 1, 2013 in CPRD, January 1, 2014 in PHARMO and January 9, 2014 in the United States data sources, and will end at the latest available data at each database at the time of analysis

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of urinary tract infections (UTI) complications
timeFrame: Day after index date up to six years
Secondary outcomes:
measure: Incidence of pyelonephritis
timeFrame: Day after index date up to six years
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Research Site
state: Delaware
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: RTI Health Solutions
name: Catherine Johannes, Dr
role: PRINCIPAL_INVESTIGATOR
References: