Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment
Completed
Conditions studied: Breast Cancer, Bladder Cancer
In brief
The primary objectives of this study are (1) to compare the incidence of breast cancer, by insulin use at cohort entry, among females with type 2 diabetes who are new users of dapagliflozin and females 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 and (2) to compare the incidence of bladder cancer, by insulin use at the index date and by pioglitazone use at the index date, among male and female patients with type 2 diabetes who are new users of dapagliflozin and those who are new users of ADs in classes other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy. Secondary objectives will compare, by insulin use at cohort entry, frequency of several measures of health care use, baseline characteristics, and incidence of selected other cancers in males and females between the two exposure cohorts.
Key facts
- Study ID
- NCT02695121
- Run by
- AstraZeneca
- People needed
- 2133575
- Starts
- 2017-01-01
- Expected to finish
- 2025-01-30
- Last updated by the study team
- 2026-04-17
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- patient was newly prescribed dapagliflozin or newly prescribed an AD (with or without other ADs) in a class other than SGLT2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy on the prescription index date
- patient is aged 40 years or older at cohort entry; and
- patient was enrolled in the data source for at least 180 days before the prescription index date.
You may not qualify if…
- any evidence of diagnosis of type 1 diabetes before cohort entry or use of insulin alone as the first recorded AD;
- any diagnosis of cancer before cohort entry (other than nonmelanoma skin cancer);
- any recording of hematuria before cohort entry;
- any cystoscopy or urine cytology performed before cohort entry;
- any breast biopsy performed before cohort entry.
Where it is running
- Research Site — Wilmington, Delaware, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Utrecht, Netherlands
- Research Site — London, United Kingdom
Full record on ClinicalTrials.gov
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