Status:
COMPLETED
Real World Glycemic Effectiveness of Linagliptin
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
40+ years
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 determi...
Eligibility Criteria
Inclusion
- ≥ 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
- ≥ 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
Key Trial Info
Start Date :
November 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2018
Estimated Enrollment :
11001 Patients enrolled
Trial Details
Trial ID
NCT03338803
Start Date
November 21 2017
End Date
February 2 2018
Last Update
May 6 2019
Active Locations (1)
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1
Optum
Eden Prairie, Minnesota, United States, 55344