Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment

NCT ID: NCT02695121

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2133575 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2025-01-30

Brief 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 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.

Detailed 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

Conditions

Breast Cancer; Bladder Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Female breast cancer

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

No interventions assigned to this group

Sex combined bladder cancer

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

No interventions assigned to this group

Male bladder cancer

male 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

No interventions assigned to this group

Female bladder cancer

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lia Gutierrez

Role: PRINCIPAL_INVESTIGATOR

RTI Health Solutions

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

Countries

United States; Netherlands; United Kingdom

Other Identifiers

EUPAS12116

Identifier Type: REGISTRY

Identifier Source: secondary_id

D1690R00007

Identifier Type: -

Identifier Source: org_study_id