FDA Approves New Oral Drug for Type 2 Diabetes

On August 1, the US Food and Drug Administration (FDA) approved the oral diabetes drug Jardiance (generic name empagliflozin) for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. The medicine, a joint development of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, joins Invokana (canagliflozin) and Farxiga (dapagliflozin) as a member of the class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.

In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Jardiance blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.

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The medicine comes in tablet strengths of 10 milligrams and 25 milligrams, to be taken once daily. The safety and effectiveness of Jardiance were established through seven clinical trials, involving 4,480 people with Type 2 diabetes, that showed improvements in fasting blood glucose levels and A1C levels (a measure of blood glucose control over the previous 2–3 months) in those taking the drug. Clinical trials also showed modest reductions in both body weight and systolic blood pressure (the top number) in people using the medicine.

In an interview with Medscape Medical News, the FDA noted that Boehringer Ingelheim had corrected manufacturing issues that initially held up approval of the medicine in March.

The FDA is requiring four trials of Jardiance once it is on the market, including one focusing on cardiovascular events; two looking at how the drug works and how safe and effective it is in children, including its effect on bone health and development; and an animal study looking at safe levels of the medicine in juveniles, with a special focus on growth and kidney and bone development.

The medicine has been studied as a stand-alone therapy and in combination with Type 2 diabetes treatments such as metformin, insulin, Actos (pioglitazone), and drugs in the sulfonylurea class. It should not be used to treat people with Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), severe kidney impairment, end-stage kidney disease, or those on dialysis.

The most common side effects in people using this medicine are urinary tract infections and female genital infections. Because of its diuretic effect, Jardiance can cause low blood pressure, which may lead to symptoms such as dizziness, fainting, or a decline in kidney function. People who are elderly, those with impaired kidney function, and those who are on diuretics for other conditions appear to be more susceptible to this risk.

For more information, see the press releases on the Eli Lilly and FDA websites.

  • Joe

    What level of improvement in fasting blood glucose was attained?

  • Diane Fennell

    Hi Joe,

    Thanks for your question. I have written to the manufacturer to find out the answer and will post it here when I hear back.

    Best,
    Diane Fennell
    Web Editor

  • pat

    Invokana I saw this on tv and I also saw the possible side effects. No thanks. I have seen too many New meds doing more hard then good. What works for one person may not work for the next one.

  • Lillie

    I am concerned how this new diabetes medication will affect a person with osteoporosis. Will it cause more bone loss? Also, how will this medication affect someone with a “familial cancer” in their genes? A sister and an aunt has had cancer. Also, how will this affect someone who has thyroid disease(hypothyroid)?

  • Diane Fennell

    Hi Joe,

    Thanks again for your question. According to Emily Baier Geary, Director of Public Relations for manufacturer Boehringer Ingelheim Pharmaceuticals, “As noted in the Jardiance prescribing information, in a clinical trial, after 24 weeks as monotherapy, mean placebo-adjusted reductions in FPG were 31 mg/dL and 36 mg/dL for JARDIANCE 10 mg and 25 mg, respectively.”

    Best,
    Diane Fennell
    Web Editor

  • Robin

    Will the medication be covered by Medicaid? If not then how much will it cost out of pocket?

  • Chrysantha

    I’ve taken Jardiance for a few weeks now. I’m also on Armour thyroid (compounded here in FL, w/lactose filler, it’s benign for me). I lay OFF the Armour one day a week. (per Dr.)
    Since I started the Jardiance I SWEAT (and I mean REALLY sweat) after I eat. EXCEPT when I don’t take my Armour.( my whole body feels HOT)
    Jardiance + Armour = sweat no matter what I eat or when I eat it.

    Jardiance alone = no sweating when I eat.

    My ‘normal’ body temp is 99.9 ( went UP in 1998 with no explanation from Dr’s) I also don’t have a thermometer right now to take my temp, so I don’t know if my temp really rises, or it’s just a weird symptom.
    I’ve left e-mail with my endo/pharmacy to see what they say. But I found this forum and I thought I’d ask.
    Thanks,
    Chrys