Real World Glycemic Effectiveness of Linagliptin

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03338803
• Other study ID #: 1218-0182
• Status: Completed
• Start date: November 21, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: February 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11001
• Est. completion date: February 2, 2018
• Est. primary completion date: February 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Linagliptin
drug

Locations

Country	Name	City	State
United States	Optum	Eden Prairie	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories	Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).; Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date.	Baseline and 60 to 180 days
Primary	Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories	Change in HbA1c among adults with type 2 diabetes mellitus (T2DM) within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories.; Change in HbA1c, was calculated for each patient by subtracting the patient's last (most recent) HbA1c value during the pre-index period (including the index date) from the patient's last (most recent) HbA1c value 60 to 180 days after the index date. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR = 90 milliliter/ minute/1.73 meter^2 and eGFR not available).	Baseline and 60 to 180 days
Secondary	Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories	Percentage of adults with T2DM who achieve HbA1c < 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined age categories (40 to 54 years, 40 to 54 years, 65 to 74 years and 75+ years).	60 to 180 days
Secondary	Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories	Percentage of adults with T2DM who achieve HbA1c < 7.0% within the 60 to 180 days following initiation of linagliptin across pre-defined renal function categories. Renal function categories were presented based on patients with a pre-index estimated glomerular filtration rate (eGFR) value (eGFR<30, eGFR 30 to 44, eGFR 45 to 59, eGFR 60 to 89, eGFR = 90 milliliter/ minute /1.73 meter^2 and eGFR not available).	60 to 180 days

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