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Real World Glycemic Effectiveness of Linagliptin | Clinical Trials | Clareo Health

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Real World Glycemic Effectiveness of Linagliptin

Real World Glycemic Effectiveness of Linagliptin Among Type 2 Diabetes Mellitus Adults by Age and Renal Function

NCT03338803•Boehringer Ingelheim

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

Eligibility

Age

40 - No limit years

Sex

ALL

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

Locations (1)

Optum

Eden Prairie, Minnesota, United States

Key Dates

Start Date

November 21, 2017

Primary Completion Date

February 2, 2018

Completion Date

February 2, 2018

Last Updated

May 6, 2019

Enrollment

11,001

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Real World Glycemic Effectiveness of Linagliptin

Inclusion Criteria

Exclusion Criteria

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