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

Exclusion 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:
• a) 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):
• 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:
• c) 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
• 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.