Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    1125000
  • sponsor
    AstraZeneca
Updated on 21 April 2021
cancer
metformin
bladder cancer
bladder tumor

Summary

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 cohort entry and pioglitazone use, 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.

Description

This is a multinational cohort database study to estimate the incidence of female breast cancer and bladder cancer, by insulin use at cohort entry, 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 a large populations.

The study will be implemented in four administrative health care data sources in three countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD); in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the HealthCore Integrated Research Database (HIRDSM); and, in the Netherlands, the PHARMO Database Network. Individuals in the databases will be included in the study if they meet the following age criteria; 40 years or older (CPRD and PHARMO), 40 to 64 years (HIRD) or 65 years or older (Medicare); and if they did not have type 1 diabetes, were treated with 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 November 13, 2012 in CPRD, November 1, 2013 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

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Breast Cancer, Breast Cancer Diagnosis, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, breast carcinoma, carcinoma of the bladder, cancer, breast, bladder tumor
Clinical Study IdentifierNCT02695121
SponsorAstraZeneca
Last Modified on21 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Bladder Carcinoma or Bladder Disorders or Breast Cancer or bladder disorder or urinary tract neoplasm or bladder cancer or Urologic Cancer or Urotheli...?
Do you have any of these conditions: breast carcinoma or carcinoma of the bladder or cancer, breast or Breast Cancer or urinary tract neoplasm or Bladder Disorders or Urologic Cancer or B...?
Do you have any of these conditions: bladder tumor or Bladder Carcinoma or Breast Cancer Diagnosis or bladder disorder or urinary tract neoplasm or breast carcinoma or Urologic Cancer or ...?
Do you have any of these conditions: breast carcinoma or bladder tumor or bladder disorder or bladder cancer or carcinoma of the bladder or Urothelial Cancer or urinary tract neoplasm or ...?
Do you have any of these conditions: Breast Cancer Diagnosis or bladder tumor or Bladder Disorders or Urologic Cancer or Bladder Carcinoma or bladder cancer or urinary tract neoplasm or c...?
Do you have any of these conditions: bladder tumor or Breast Cancer or carcinoma of the bladder or breast carcinoma or bladder disorder or Urologic Cancer or cancer, breast or Breast Canc...?
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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note