- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02695121
Cancer in Patients on Dapagliflozin and Other Antidiabetic Treatment
Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Utrecht, Netherlands
- Recruiting
- Research Site
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London, United Kingdom
- Recruiting
- Research Site
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Delaware
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Wilmington, Delaware, United States
- Recruiting
- Research Site
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District of Columbia
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Washington, District of Columbia, United States
- Recruiting
- Research Site
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Washington, District of Columbia, United States
- Not yet recruiting
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
- patient is aged 40 years or older at cohort entry; and
- patient was enrolled in the data source for at least 180 days before the prescription index date.
Exclusion Criteria:
- any evidence of diagnosis of type 1 diabetes before cohort entry or use of insulin alone as the first recorded AD;
- any diagnosis of cancer before cohort entry (other than nonmelanoma skin cancer);
- any recording of hematuria before cohort entry;
- any cystoscopy or urine cytology performed before cohort entry;
- any breast biopsy performed before cohort entry.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of breast cancer
Time Frame: Index day up to twelve years
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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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Index day up to twelve years
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Incidence of bladder cancer
Time Frame: Index day up to twelve years
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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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Index day up to twelve years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of compsite cancer outcomes
Time Frame: Index day up to twelve years
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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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Index day up to twelve years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lia Gutierrez, RTI Health Solutions
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1690R00007
- EUPAS12116 (Registry Identifier: ENCePP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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