Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT05663515 (EXCEED) for Pancreatic Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
AstraZenecaA 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 (EXCEED) 24,000 Observational
EXCEED - 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
- EXCEED
- D5551R00015
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Initiators of exenatide Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide during the study period, 2006 to 2023 | Exenatide 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. |
Initiators of non-GLP-1 RA based glucose lowering drugs Patients with T2DM, aged 18 years or older, who initiated treatment with non-GLP-1 RA based glucose lowering drugs during the study period, 2006 to 2023 | Non-GLP-1 RA based glucose lowering drugs Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study period. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence rate of primary diagnosis of pancreatic cancer among exenatide exposed population | To estimate the incidence rate (IR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM. | Follow-up starts from the index date to the study completion, an average of 1.5 years or less |
Hazard ratio of primary diagnosis of pancreatic cancer among exenatide exposed population | To estimate the hazard ratio (HR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM. | Follow-up starts from thr index date to the study completion, an average of 1.5 years or less |
- Aged 18 years or older at the index date
- Individual level data on prescriptions, diagnoses and medical history is available for a minimum of 12 months prior to the index date
- 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:
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):
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:
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.
- 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.
- A diagnosis of gestational diabetes during the baseline period or on index date.
- 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.
- History of any cancer on or prior to index date. The only exception is that nonmelanoma skin cancer does not lead to exclusion.
- History of any acute pancreatitis, other diseases of the pancreas, or disorders of the pancreas on or prior to index date.
- One or more prescriptions (or dispensed prescriptions) of a GLP-1 RA (incretin mimetics) other than exenatide on or prior to index date.
- One or more prescriptions (or dispensed prescriptions) of DPP-4i (incretin mimetics) on or prior to the index date.
AstraZenecaIQVIA Pvt. Ltd