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
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Netherlands, United Kingdom,
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 |
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