Real World Glycemic Effectiveness of Linagliptin

Inclusion Criteria:

- ≥ 1 written prescription for linagliptin (Tradjenta®, Jentadueto®, or Jentadueto
XR®)in the EHR (electronic health record) data during the identification period

- ≥ 40 years of age based on the year of the index date

- First active date in the EHR is ≥ 180 days prior to the index date

- ≥ 1 diagnosis code representing T2DM (type 2 diabetes) in the EHR data during the
180-day pre-index period or on the index date

- ≥ 1 HbA1c value during the 180-day pre-index period or on the index date

- ≥ 1 HbA1c value 60 to 180 days after the index date

Exclusion Criteria:

- ≥ 1 written prescription, medication administration or medication history record
forlinagliptin or other DPP-4 (dipeptidyl peptidase) inhibitor in the EHR data during
the 180-day pre-index period

- ≥ 1 written prescription or medication administration for a new antihyperglycemic
medication other than linagliptin on the index date New antihyperglycemic medication
will be defined as a written prescription or medication administration for any
antihyperglycemic medication that was not present in the patient's written
prescription, medication administration, or medication history records during the
180-day pre-index period.

Individual antihyperglycemic medications will be distinguished by generic name using the
column labelled "Medication Name" in Tables 2 through 13. Combination products containing
two generic ingredients will be considered as two distinct antihyperglycemic medications
Note: This exclusion criterion is designed to exclude patients from the study sample if
they start a new antihyperglycemic medication other than linagliptin on the index date.
Patients that start a new antihyperglycemic medication in the follow-up period will not be
removed from the study sample to avoid creating a biased sample. Addition of a new
antihyperglycemic medication during follow-up will be evaluated through the sensitivity
analysis described in Section 9.7.4.4. While we will be capturing additions of new
therapies, discontinuation of linagliptin is not able to be accurately measured in
electronic record data. The electronic record data capture prescriptions written by a
prescriber, but it is not possible to know if patients received and adhered to their
medication and there are no structured data fields to identify if and when a medication was
discontinued by the patient or the provider

- ≥ 1 diagnosis code or procedure code representing renal transplant, solid organ
transplant, or bone marrow transplant in the EHR data during the 180-day pre-index
period or on the index date

- ≥ 1 diagnosis code representing malignancy in the EHR data during the 180-day preindex
period or on the index date