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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
Sponsor:
Collaborators:
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Canadian Network for Observational Drug Effect Studies, CNODES

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: DPP-4 inhibitors Drug: GLP-1 analogs Drug: Sulfonylureas Drug: Biguanides Drug: Thiazolidinediones Drug: Alpha-glucosidase inhibitors Drug: Meglitinides

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Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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:
  • incretin-based drugs
  • sitagliptin
  • vildagliptin
  • saxagliptin

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:
  • incretin-based drugs
  • exenatide
  • liraglutide
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.
 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:
  • oral hypoglycemic agent
  • glibenclamide
  • chlorpropamide
  • tolbutamide
  • glibornuride
  • tolazamide
  • carbutamide
  • glipizide
  • gliquidone
  • gliclazide
  • metahexamide
  • glisoxepide
  • glimepiride
  • acetohexamide
  • glymidine
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.
 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:
  • oral hypoglycemic agent
  • phenformin
  • metformin
  • buformin

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:
  • oral hypoglycemic agent
  • troglitazone
  • rosiglitazone
  • pioglitazone

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:
  • oral hypoglycemic agent
  • acarbose
  • miglitol
  • voglibose

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:
  • oral hypoglycemic agent
  • repaglinide
  • nateglinide


Outcome Measures
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Primary Outcome Measures :
  1. 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



Eligibility Criteria
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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
Study Population
In each jurisdiction, a base cohort will be assembled including all patients with a first-ever prescription for a non-insulin anti-diabetic drug. Base cohort entry is defined as the date of prescription or dispensation of the first-ever non-insulin anti-diabetic drug. From this base cohort, a study cohort will be formed consisting of all patients who initiated a new anti-diabetic drug class during the year in which incretin-based drugs entered the market in each jurisdiction or any time thereafter. Study cohort entry is defined by the prescription date of the newly-prescribed drug class.
Criteria

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
Contacts and Locations
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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): NCT02475499


Locations
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Canada, Quebec
Lady Davis Institute for Medical Research, Jewish General Hospital
Montreal, Quebec, Canada, H3T1E2
Sponsors and Collaborators
Canadian Network for Observational Drug Effect Studies, CNODES
Drug Safety and Effectiveness Network, Canada
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Pierre Ernst, MD, MSc Lady Davis Institute for Medical Research, Jewish General Hospital - McGill University
More Information
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Additional Information:
This organization's website describing general functions, other CNODES projects, and investigator profiles.  This link exits the ClinicalTrials.gov site

Publications of Results:

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Responsible Party: Canadian Network for Observational Drug Effect Studies, CNODES
ClinicalTrials.gov Identifier: NCT02475499     History of Changes
Other Study ID Numbers: Q13-06A
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Keywords provided by Canadian Network for Observational Drug Effect Studies, CNODES:
Incretins
Antidiabetic agents
Pancreatic Cancer
Additional relevant MeSH terms:
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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
Sitagliptin Phosphate
Liraglutide
Exenatide
 Saxagliptin
Vildagliptin
2,4-thiazolidinedione
Biguanides
Meglitinide
Dipeptidyl-Peptidase IV Inhibitors
Glycoside Hydrolase Inhibitors
Hypoglycemic Agents
Incretins
Physiological Effects of Drugs
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action