Comparative Effectiveness of Empagliflozin in the US
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | October 16, 2017 |
| End Date: | November 15, 2021 |
Non-interventional Study on the Effectiveness and Safety of Empagliflozin Compared With DPP-4 Inhibitors in Patients With Type 2 Diabetes in the United States
Empagliflozin, a sodium glucose co-transporter 2 (SGLT-2) inhibitor, was launched as a
treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with
several previous cardiovascular outcomes trials, which failed to demonstrate an association
with a higher or a lower risk of cardiovascular outcomes associated with members of other
recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at
high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a
reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause
mortality.However, these and other findings arising from an extensive clinical trial program
aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be
demonstrated in a non-trial environment. This study aims to investigate the transferability
of the effects demonstrated in dedicated randomized clinical studies to a broader population
under real world conditions.
treatment for type 2 diabetes mellitus (T2DM) in the U.S. in August 2014. In contrast with
several previous cardiovascular outcomes trials, which failed to demonstrate an association
with a higher or a lower risk of cardiovascular outcomes associated with members of other
recently marketed antidiabetic classes, the EMPA-REG OUTCOME trial has shown that patients at
high cardiovascular risk randomized to empagliflozin vs. placebo, were associated with a
reduced risk of hospitalization for heart failure, cardiovascular mortality, and all-cause
mortality.However, these and other findings arising from an extensive clinical trial program
aimed at evaluating the efficacy and safety profile for empagliflozin have yet to be
demonstrated in a non-trial environment. This study aims to investigate the transferability
of the effects demonstrated in dedicated randomized clinical studies to a broader population
under real world conditions.
Inclusion criteria:
- Patients >= 18 years old
- Patients initiating empagliflozin or a DPP-4 inhibitor (sitagliptin,
saxagliptin,linagliptin, alogliptin) within the study period. Initiation will be
defined as no use of SGLT-2 inhibitors or DPP-4 inhibitors in the previous 12 months
- restriction to patients with a diagnosis of T2DM (ICD-9 Dx code of 250.x0 or250.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 ICD-9 Dx code of 250.x1 or 250.x3 or ICD-10 Dx code of E10.x 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
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