NCT02695121Completed
Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment
Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2133575 (actual)
- First submitted
- 18 Feb 2016
- Start date
- 1 Jan 2017
- Primary completion date
- 30 Jan 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Bladder cancer, Type 2 diabetes
- NCT number
- NCT02695121
What you commit to
- Study type: Observational
- Participants enrolled: 2133575
- From 1 Jan 2017 to the primary completion date, 30 Jan 2025
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Other
- any recording of hematuria before cohort entry;
- any cystoscopy or urine cytology performed before cohort entry;
- any breast biopsy performed before cohort entry.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.