Incretin-based Drugs and Pancreatic Cancer
NCT02475499 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 886172
Last updated 2016-03-14
Summary
The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone in or combination with other anti-diabetic drugs are associated with an increased risk of pancreatic cancer (PC) compared to sulfonylureas.
The investigators will carry out separate population based cohort studies using administrative health databases in five jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for PC. The results from the separate sites will be combined to provide an overall assessment of the risk of PC in users of incretin-based drugs and by class of incretin-based drugs.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
DPP-4 inhibitors
Ever-use of DPP-4 inhibitors (ATC A10BH, A10BD07-A10BD13) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
- DRUG
-
GLP-1 analogs
Ever-use of GLP-1 analogs (ATC A10BX04, A10BX07) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
- DRUG
-
Sulfonylureas
Ever-use of sulfonylureas (ATC A10BB or A10BC) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
- DRUG
-
Biguanides
Ever-use of biguanides (ATC A10BA) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
- DRUG
-
Thiazolidinediones
Ever-use of thiazolidinediones (ATC A10BG) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
- DRUG
-
Alpha-glucosidase inhibitors
Ever-use of alpha-glucosidase inhibitors (ATC A10BF) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
- DRUG
-
Meglitinides
Ever-use of meglitinides (ATC A10BX02, A10BX03) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
Sponsors & Collaborators
-
Drug Safety and Effectiveness Network, Canada
collaborator OTHER -
Canadian Institutes of Health Research (CIHR)
collaborator OTHER_GOV -
Canadian Network for Observational Drug Effect Studies, CNODES
lead OTHER
Principal Investigators
-
Pierre Ernst, MD, MSc · Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2015-04-30
- Completion
- 2015-04-30
Countries
- Canada
Study Locations
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