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Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment

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ClinicalTrials.gov Identifier: NCT02695121
Recruitment Status : Recruiting
First Posted : March 1, 2016
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Breast Cancer Bladder Cancer

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


Study Type : Observational
Estimated Enrollment : 99999 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
Actual Study Start Date : February 29, 2016
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer




Primary Outcome Measures :
  1. Incidence of breast cancer [ Time Frame: Index day up to twelve years ]
    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.

  2. Incidence of bladder cancer [ Time Frame: Index day up to twelve years ]
    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.


Secondary Outcome Measures :
  1. Incidence of compsite cancer outcomes [ Time Frame: Index day up to twelve years ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria. Comparator patients will be randomly selected in a 4:1 ratio to the dapagliflozin patients.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02695121


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
United States, Delaware
Research Site Recruiting
Wilmington, Delaware, United States
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States
Netherlands
Research Site Recruiting
Utrecht, Netherlands
United Kingdom
Research Site Recruiting
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Lia Gutierrez RTI Health Solutions

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02695121     History of Changes
Other Study ID Numbers: D1690R00007
EUPAS12116 ( Registry Identifier: ENCePP )
First Posted: March 1, 2016    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs