Real World Glycemic Effectiveness of Linagliptin

NCT ID: NCT03338803

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11001 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2018-02-02

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with a written prescription for linagliptin

Linagliptin

Intervention Type: DRUG

drug

Interventions

Linagliptin

drug

Intervention Type: DRUG

Other Intervention Names

ONDERO, TRAJENTA, TRAYENTA, TRAZENTA, TRADJENTA

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Optum

Eden Prairie, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1218-0182

Identifier Type: -

Identifier Source: org_study_id