Comparative Effectiveness of Empagliflozin in the US

Launched by BOEHRINGER INGELHEIM · Nov 30, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of empagliflozin, a medication used to treat type 2 diabetes, in real-world settings. Empagliflozin has previously been shown to help reduce the risk of serious heart issues, like heart failure and death, in patients with diabetes who are at high risk for heart problems. The goal of this study is to see if these positive effects can also be observed in a broader group of patients outside of clinical trials.

To be eligible for this study, participants must be at least 18 years old and have been diagnosed with type 2 diabetes. They should also be starting treatment with empagliflozin or a different diabetes medication called a DPP-4 inhibitor. However, people with certain conditions, such as type 1 diabetes, serious kidney problems, or a history of cancer in the last five years, cannot participate. Throughout the study, participants will help researchers understand how well empagliflozin works in everyday medical practice, which is important for ensuring that patients receive the best possible care.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Patients \>= 18 years old for Marketscan and Optum, and \>=65 years old for Medicare only
• • Patients initiating empagliflozin or a DPP-4 inhibitor within the study period. Initiation was defined as no use of SGLT-2 inhibitors (canagliflozin, dapagliflozin, ertugliflozin) or DPP-4 inhibitors in the previous 12 months.
• • Restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or 250.x2; ICD-10 Dx code of E11.x) in the 12 months prior to drug initiation.
• Exclusion criteria:
• • Patients with missing or ambiguous age or sex information.
• • All patients who have less than 12 months of continuous registration in the database prior to initiation of empagliflozin or a DPP-4 inhibitor will be excluded.
• • Patients with type 1 diabetes mellitus (T1DM) defined as at least 1 inpatient or outpatient codes in the 12 months prior to drug initiation.
• • Secondary diabetes, and gestational diabetes in the 12 months prior to drug initiation
• • History of cancer in the 5 years prior to drug initiation
• • End-stage renal disease (ESRD) in the 12 months prior to drug initiation
• • HIV diagnosis or treatment in the 12 months prior to drug initiation
• • Organ transplant in the 12 months prior to drug initiation
• • Patients that were in nursing homes in the 12 months prior to drug initiation
• • Patients with concomitant SGLT-2 inhibitor and DPP-4 inhibitor initiation will also be excluded.
• • Patients initiating more than one DPP-4i on cohort entry date will additionally be excluded Additional exclusion criteria apply.