Trial Title:
A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients Who Initiated Exenatide as Compared With Those Who Initiated Other Non-Glucagon-Like Peptide 1 Receptor Agonists Based Glucose Lowering Drugs
NCT ID:
NCT05663515
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Insulin
Insulin, Globin Zinc
Exenatide
Biguanides
2,4-thiazolidinedione
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Exenatide
Description:
All patients initiating exenatide during the study period will be identified by ATC codes
and be included in the exenatide group in a hierarchical manner, regardless of previous
use of non-GLP-1 RA based glucose lowering drugs.
Arm group label:
Initiators of exenatide
Other name:
BYETTA, BYDUREON/BYDUREON BCise
Intervention type:
Drug
Intervention name:
Non-GLP-1 RA based glucose lowering drugs
Description:
Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study
period.
Arm group label:
Initiators of non-GLP-1 RA based glucose lowering drugs
Other name:
Insulin/analogues (excl. A10AE54, A10A56), Biguanide, Sulfonylurea, Sulfonamide (heterocycl.), combined oral GLD (excl. DPP-4i), Alpha glucose inhib., Thiazolidinedione, SGLT2i, Oth. GLD excl. insulin
Summary:
EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk
of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who
initiated exenatide compared to those who initiated other non-glucagon like peptide 1
receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be
collected from secondary data sources across 7 European countries. The study will be
conducted as a multi-country, long-term, retrospective, observational database study.
Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs
(comparator group) based on propensity score and calendar period of study entry. All
analyses for pancreatic cancer will be conducted in the matched study population using an
"intention-to-treat" approach. The study will use information from 8 data sources in 7
European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and
Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with
exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be
included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from
recordings of prescriptions or insurance claims registrations as available in the
different data sources. The outcome of pancreatic cancer will be defined as a primary
diagnosis of pancreatic cancer during follow-up.
Criteria for eligibility:
Study pop:
Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or
non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure
to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of
prescriptions or insurance claims registrations as available in the different data
sources.
Sampling method:
Non-Probability Sample
Criteria:
For inclusion in either exposure group, all of the following inclusion criteria must be
fulfilled:
1. Aged 18 years or older at the index date
2. Individual level data on prescriptions, diagnoses and medical history is available
for a minimum of 12 months prior to the index date
3. A diagnosis of T2DM on index date or prior to index date
For inclusion in the overall exenatide exposure group, the following criterion must be
fulfilled:
1. One incident prescription (or incident dispensed prescription) for exenatide (BYETTA
or BYDUREON/ BYDUREON BCise) between the start and 12 months before the end of the
study period. This incident prescription must have succeeded a prescription of a GLD
of another drug class during the baseline period.
For inclusion in the BYDUREON/ BYDUREON BCise exposure group, for the analyses of
the secondary objective, the criterion a) is substituted with criterion b):
2. One incident prescription (or incident dispensed prescription) for BYDUREON/
BYDUREON BCise between the start and 12 months before the end of the study period.
This incident prescription must have succeeded a prescription of a GLD of another
drug class during the baseline period.
For inclusion in the comparator group, the following criterion must be fulfilled:
3. One incident prescription (or incident dispensed prescription) of a GLD between the
start and 12 months before the end of the study period. The GLD must not be a
DPP-4i, a GLP-1 RA, or a combination with either a DPP-4i or a GLP-1 RA. This
incident prescription must have succeeded a prescription of a GLD of another drug
class during the baseline period.
Patients are not eligible for any of the study population groups if they fulfil any of
the following exclusion criteria:
1. A diagnosis of type 1 diabetes mellitus (T1DM) on index date or a diagnosis of T1DM
during the baseline period that is not succeeded by a T2DM diagnosis during the
remaining part of the baseline period.
2. A diagnosis of gestational diabetes during the baseline period or on index date.
3. A diagnosis of polycystic ovarian syndrome during the baseline period or on index
date in combination with exposure to metformin (Anatomical Therapeutic Chemical
Classification System (ATC) code of the World Health Organization (WHO): A10BA02) as
the only GLD on index date or during the baseline period.
4. History of any cancer on or prior to index date. The only exception is that
nonmelanoma skin cancer does not lead to exclusion.
5. History of any acute pancreatitis, other diseases of the pancreas, or disorders of
the pancreas on or prior to index date.
6. One or more prescriptions (or dispensed prescriptions) of a GLP-1 RA (incretin
mimetics) other than exenatide on or prior to index date.
7. One or more prescriptions (or dispensed prescriptions) of DPP-4i (incretin mimetics)
on or prior to the index date.
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Copenhagen
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Helsinki
Country:
Finland
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Bergen
Country:
Norway
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Vänersborg
Country:
Sweden
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
Edinburgh
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Research Site
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
September 30, 2024
Completion date:
March 2, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Collaborator:
Agency:
IQVIA Pvt. Ltd
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05663515
