First-In-Class Combo Diabetes Drug Approved; Inhalable Insulin Now Available

First-In-Class Combo Diabetes Drug Approved

On February 2, the U.S. Food and Drug Administration (FDA) approved the first-in-class combination oral diabetes drug Glyxambi for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. The medicine, a development of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, combines empagliflozin (brand name Jardiance), an SGLT2 inhibitor, and linagliptin (Tradjenta), a DPP-4 inhibitor.

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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, empagliflozin blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.

DPP-4 inhibitors such as linagliptin work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-4 breaks down hormones called incretins, which stimulate the release of insulin, slow stomach emptying, inhibit the release of glucagon (a hormone that signals the liver to release glucose), and enhance the survival and growth of the insulin-producing beta cells. With DPP-4 inhibited, the incretins have longer to carry out these actions.

Glyxambi, which is the first combination tablet of a DPP-4 inhibitor and an SGLT2 inhibitor approved in the United States, will be offered in doses of 10 milligrams or 25 milligrams of empagliflozin with 5 milligrams of linagliptin, to be taken once a day in the morning.

This medicine should not be used in people who have Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), severe kidney problems, or in those who are on dialysis. The most commonly reported side effects of Glyxambi are urinary tract infection, nasopharyngitis (inflammation of the nose and pharynx), and upper respiratory tract infection.

For more information about Glyxambi, see the press releases on the Eli Lilly website or the medicine’s official website.

Inhalable Insulin Now Available
In other news, the inhalable insulin/inhaler combination Afrezza, developed by MannKind Corporation and licensed by pharmaceutical company Sanofi, is now available to U.S. consumers by prescription in retail pharmacies nationwide. Afrezza, which was approved by the FDA in June 2014, is comprised of an ultrarapid-acting premeal insulin powder and a whistle-size device that the powder is loaded into for inhalation.

To learn more about Afrezza, click here or see the official website.

  • Brenda Engelhart

    What’s the side effects?

    • Oicangi Relos

      For farther discussion on Afrezza you should visit TuDiabetes.com. Several members have posted experiences and results that go well beyond what I have seen anywhere else.
      The very low probability of hypos is something many have documented on with remarkable results. Also, while I am not on Afrezza yet, several have documented a mild cough after inhalation that tends to go away after just a few days, 4 or 5. There is still many unknowns about Afrezza but so far so it would seem users are tweeting timing in dosage, something that seems to be even more important than dosage itself, to their advantage.

  • wendylea

    I would like to know the side effects also and what is the cost going to be compared to injectiables?

  • Diane Fennell

    Thank you for your questions. The most common side effects in people using Afrezza are low blood glucose, cough, and throat pain or irritation. The medicine is priced comparably to fast-acting injectable insulin in pens, with a retail price ranging from roughly $215 to $270.

    Best,
    Diane Fennell
    Web Editor

    • concerned_newfie

      You guys in the USA are being absolutely raked over the coals for drug prices. Its $140 Canadian for a box of 5 Apidra pens here, with a 20% co-pay if you got the insurance. Comparable is a relative term.

      That being said, it sure looks interesting. Question is, are they working on a long term Lantus equivalent? Now if both were available and the ‘refrigeration’ of your stockpile was no longer required. Now that would be a god send.

      I say that as I plan to travel soon and dragging insulin in a small chilled container through the jungles of south east Asia in hostels that don’t have refrigerators in the rooms would be simply amazing.