Incretin-based Drugs and Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT02475499 |
Recruitment Status :
Completed
First Posted : June 18, 2015
Last Update Posted : March 14, 2016
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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.
Condition or disease | Intervention/treatment |
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Diabetes Mellitus, Type 2 | Drug: DPP-4 inhibitors Drug: GLP-1 analogs Drug: Sulfonylureas Drug: Biguanides Drug: Thiazolidinediones Drug: Alpha-glucosidase inhibitors Drug: Meglitinides |

Study Type : | Observational |
Actual Enrollment : | 886172 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | The Use of Incretin-based Drugs and the Risk of Pancreatic Cancer in Patients With Type 2 Diabetes |
Study Start Date : | March 2014 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Group/Cohort | Intervention/treatment |
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Treated with incretins
Ever-use of incretin-based drugs ((DPP-4 inhibitors [sitagliptin, vildagliptin, and saxagliptin] or GLP-1 analogs [exenatide, liraglutide]) between (and including) base cohort entry and the index day - 365 days.
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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.
Other Names:
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.
Other Names:
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Treated with sulfonylureas
Ever-use of sulfonylureas between (and including) base cohort entry and the index day - 365 days, and never-use of incretin-based drugs.
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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.
Other Names:
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Treated with other antidiabetic agents
Ever-use of other antidiabetic agents (biguanides, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides) between (and including) base cohort entry and the index day - 365 days, with never-use of incretin-based drugs and never use of sulfonylureas.
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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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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- Incident pancreatic cancer [ Time Frame: Patients were followed from the date of study cohort entry until hospitalization for incident pancreatic cancer, censoring, or for up to 79 months. ]
Incident cases of pancreatic cancer recorded in a hospital database with the following ICD codes:
ICD-9:157.0-157.9
ICD-10:C25.x

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Patients with a first-ever prescription for a non-insulin anti-diabetic drug, including biguanides, sulfonylureas, thiazolidinediones, DPP-4 inhibitors, GLP-1 analogs, alpha-glucosidase inhibitors, meglitinides or combinations of these drugs from the earliest availability of data at each site to the last date of availability of data.
- Patients with at least 1 year of history in the database.
- Patients at least 18 years of age.
Exclusion Criteria:
- Patients who died or left the cohort before the year the first incretin-based drug entered the market.
- Patients who never added-on or switched to a new anti-diabetic drug after incretin-based drugs entered the market up until June 30, 2014.
- Patients with a previous diagnosis of pancreatic cancer, those who underwent pancreatectomy or were diagnosed with congenital defects of the pancreas at any time prior to study cohort entry.
- Patients with less than 365 days of follow-up after study cohort entry

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): NCT02475499
Canada, Quebec | |
Lady Davis Institute for Medical Research, Jewish General Hospital | |
Montreal, Quebec, Canada, H3T1E2 |
Principal Investigator: | Pierre Ernst, MD, MSc | Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University |
Publications of Results:
Responsible Party: | Canadian Network for Observational Drug Effect Studies, CNODES |
ClinicalTrials.gov Identifier: | NCT02475499 |
Other Study ID Numbers: |
Q13-06A |
First Posted: | June 18, 2015 Key Record Dates |
Last Update Posted: | March 14, 2016 |
Last Verified: | March 2016 |
Incretins Antidiabetic agents Pancreatic Cancer |
Pancreatic Neoplasms Diabetes Mellitus, Type 2 Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Metformin Pioglitazone Sitagliptin Phosphate |
Liraglutide Exenatide Glimepiride Rosiglitazone Saxagliptin Vildagliptin Acarbose Repaglinide Hypoglycemic Agents Gliclazide Glipizide Tolbutamide Voglibose Biguanides Nateglinide |