Real World Glycemic Effectiveness of Linagliptin

Boehringer Ingelheim

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Linagliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT03338803

1218-0182

Details and patient eligibility

About

A non-interventional cohort study using existing data from patients in the Optum Clinical Database which contains electronic health record (EHR) data from providers across the United States to determine whether there is comparable effectiveness of linagliptin on glycemic effectiveness

Enrollment: 11,001 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 Type 2 diabetes (T2DM) 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 for linagliptin or other dipeptidyl peptidase (DPP-4) 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

Trial design

11,001 participants in 1 patient group

Patients with a written prescription for linagliptin

Treatment:

Drug: Linagliptin