Massive study probes cancer risk of common diabetes drug
NCT ID NCT02695121
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed study analyzed health records from over 2 million people with type 2 diabetes to see if those taking dapagliflozin had a different risk of breast or bladder cancer compared to those on other diabetes medications. Researchers tracked cancer diagnoses for up to 12 years. The goal is to better understand the long-term safety of dapagliflozin.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dapagliflozin
- What this could lead to
- If this study finds no increased cancer risk, it could reassure patients and doctors that dapagliflozin is safe to use for type 2 diabetes.
- What could go wrong
- This is an observational study, not a controlled trial, so it can only show links, not cause and effect. Results may be influenced by other factors like patient health or lifestyle.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
2,133,575 people
The number who actually took part.
- Started
-
Jan 2017
- Finished
-
Jan 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. Comparator patients will be randomly selected in a 4:1 ratio to the dapagliflozin patients.
- Ages
-
40 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 2. patient is aged 40 years or older at cohort entry; and 3. patient was enrolled in the data source for at least 180 days before the prescription index date. Exclusion Criteria: 1. any evidence of diagnosis of type 1 diabetes before cohort entry or use of insulin alone as the first recorded AD; 2. any diagnosis of cancer before cohort entry (other than nonmelanoma skin cancer); 3. any recording of hematuria before cohort entry; 4. any cystoscopy or urine cytology performed before cohort entry; 5. any breast biopsy performed before cohort entry.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
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
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