Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment

Breast Cancer Clinical Trial

Official title:

Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02695121
• Other study ID #: D1690R00007
• Secondary ID: EUPAS12116
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1125000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
Netherlands	Research Site	Utrecht
United Kingdom	Research Site	London
United States	Research Site	Washington	District of Columbia
United States	Research Site	Washington	District of Columbia
United States	Research Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of breast cancer	Patients will be followed from their index date (date of first study drug prescription or dispensing) until the earliest of occurrence of one of the following: first occurrence of any one of the study endpoints, death, addition of a non-dapagliflozin SGLT2 inhibitor, disenrollment from the study database or transfer out of the GP practice, or end of the study period up to twelve years.	Index day up to twelve years
Primary	Incidence of bladder cancer	Patients will be followed from their index date (date of first study drug prescription or dispensing) until the earliest of occurrence of one of the following: first occurrence of any one of the study endpoints, death, addition of a non-dapagliflozin SGLT2 inhibitor, disenrollment from the study database or transfer out of the GP practice, or end of the study period up to twelve years.	Index day up to twelve years
Secondary	Incidence of compsite cancer outcomes	Patients will be followed from their index date (date of first study drug prescription or dispensing) until the earliest of occurrence of one of the following: first occurrence of any one of the study endpoints, death, addition of a non-dapagliflozin SGLT2 inhibitor, disenrollment from the study database or transfer out of the GP practice, or end of the study period up to twelve years.	Index day up to twelve years