Clinical trial NCT03338803: Real World Glycemic Effectiveness of Linagliptin
Official title: Real World Glycemic Effectiveness of Linagliptin Among Type 2 Diabetes Mellitus Adults by Age and Renal Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2017-11-09
Enrollment: 11001
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 effectivenes

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


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

Primary outcomes:
measure: Change in Glycosylated Hemoglobin (HbA1c) Across Age Categories
timeFrame: Baseline and 60 to 180 days
measure: Change in Glycosylated Hemoglobin (HbA1c) Across Renal Function Categories
timeFrame: Baseline and 60 to 180 days
Secondary outcomes:
measure: Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across the Pre-defined Age Categories
timeFrame: 60 to 180 days
measure: Percentage of Adults With T2DM Who Achieve HbA1c < 7.0% Across Renal Function Categories
timeFrame: 60 to 180 days
Other outcomes:
Locations:
city: Eden Prairie
country: United States
facility: Optum
state: Minnesota
Study officials:
References: