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BRIEF TITLE: Risk of Bladder Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments

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


  • Org Study ID: D1690R00007
  • Secondary ID: EUPAS12116
  • NCT ID: NCT02695121
  • NCT Alias:
  • Sponsor: AstraZeneca - Industry
  • Source: AstraZeneca

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 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.

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.

Overal Status Start Date Phase Study Type
Recruiting February 29, 2016 Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of breast cancer

Primary Outcome 1 - Time Frame: Index day up to twelve years

Primary Outcome 2 - Measure: Incidence of bladder cancer

Primary Outcome 2 - Time Frame: Index day up to twelve years

Condition:

  • Breast Cancer
  • Bladder Cancer

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.
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Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Lia Gutierrez

Role: Principal Investigator

Affiliation: RTI Health Solutions

Overall Contact

Name: AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

Locations

Facility Status Contact
Research Site
Wilmington, Delaware
United States
Recruiting
Research Site
Washington, District of Columbia
United States
Recruiting
Research Site
Utrecht,
Netherlands
Recruiting
Research Site
London,
United Kingdom
Recruiting