Jardiance (empagliflozin)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved August 2014

Specific Treatments:

type II diabetes

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General Information

Jardiance (empagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Jardiance is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus.

Jardiance is supplied as a tablet for oral administration. The recommended dose is 10 mg once daily in the morning, taken with or without food. In patients tolerating Jardiance, the dose may be increased to 25 mg.

Clinical Results

FDA Approval

The FDA approval of Jardiance was based on a monotherapy study and in combination study with metformin, sulfonylurea, pioglitazone and insulin. 

Monotherapy Study

A double-blind, placebo-controlled study enrolled 986 treatment-naïve subjects with inadequately controlled type II diabetes. The subjects entered an open-label placebo run-in for two weeks. At the end of the run-in period, subjects who remained inadequately controlled and had an HbA1c between 7 and 10% were randomized to placebo, Jardiance 10 mg, Jardiance 25 mg, or a reference comparator. At Week 24, treatment with Jardiance 10 mg or 25 mg daily provided statistically significant reductions in HbA1c (p-value <0.0001), fasting plasma glucose (FPG), and body weight compared with placebo. At Week 24, systolic blood pressure was statistically significantly reduced compared to placebo by -2.6 mmHg (placebo-adjusted, p-value=0.0231) in subjects randomized to 10 mg of Jardiance and by -3.4 mmHg (placebo-corrected, p-value=0.0028) in subjects randomized to 25 mg of Jardiance.

Combination Studies

In various combination studies, treatment with Jardiance 10 mg or 25 mg daily provided statistically significant reductions in HbA1c (p-value <0.0001), FPG, and body weight compared with placebo. 

Side Effects

Adverse effects associated with the use of Jardiance may include, but are not limited to, the following:

urinary tract infections

female genital mycotic infections

 

Mechanism of Action

Jardiance (empagliflozin) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion. 

Additional Information

For additional information regarding Jardiance or type II diabetes, please visit https://www.jardiance.com/