FDA Approves New Diabetes Drug

On May 2, the US Food and Drug Administration (FDA) approved the diabetes medicine linagliptin (brand name Tradjenta), developed by Boehringer Ingelheim Pharmaceuticals, Inc., and Eli Lilly and Company. Tradjenta is a new member of the class of drugs known as DPP-4 inhibitors. (Saxagliptin [Januvia] and sitagliptin [Onglyza] are the other members of this drug class.)


DPP-4 inhibitors 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.

In clinical trials, Tradjenta has been associated with reductions in A1C (an indicator of blood glucose control over the previous 2–3 months) of up to 0.7% compared to placebo (inactive treatment), and has also been shown to reduce fasting glucose and after-meal glucose levels.

The tablets will be offered in a 5-milligram dose to be taken once daily, with or without food. Tradjenta is approved for use alone or in combination with metformin (Glucophage and others), sulfonylureas (DiaBeta, Glynase, Micronase, Glucotrol, Glucotrol XL, Amaryl), or pioglitazone (Actos) in adults with Type 2 diabetes. No dose adjustment is recommended for people with kidney or liver impairment.

This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body). The most common side effects in people using Tradjenta are stuffy or runny nose and sore throat.

For more information, see the press release on the Eli Lilly Web site or see Tradjenta’s Web site.

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  • Steve Parker, M.D.

    Of the three DPP-4 inhibitors, linagliptin may end up as the market leader. The dosing is more straightforward. It may sligthly increase the risk of pancreatitis, like sitagliptin.

    The drug does seem to be well-tolerated, with the most common side effects being runny or stuffy nose, or a sore throat.


  • R Gillis

    What is the advantage of Tradjenta over Januvia? Are there fewer side effects? How does it compare to lowering HbA1C compared to Januvia?

  • Joshua Meltzer

    Does anyone know how the price compares with Januvia (which seems to be very expensive)?

  • Ferne

    What is the price for the new drug? Some are so expensive older Americans can’t afford them or drug insurance plans won’t cover.

  • Bev Hammond

    I live in England – I am on insulin and Metformin. Is there any chance this drug will be released here? I would love to not have to inject twice a day!

  • nancy

    when taking insulin a resding of 486 how do you determin how much to take?

  • Diane Fennell

    Hello everyone,

    Thank you for your questions. Tradjenta and Januvia both lower HbA1c by roughly 0.7%. A main difference between the two medicines is the dosing: No dosage adjustments are recommended in people with kidney or liver impairment for Tradjenta, while dose adjustments of Januvia are recommended for people with kidney disease. I unfortunately was not able to find any information about pricing or availability of Tradjenta outside the United States.

    Thanks for your interest in Diabetes Self-Management!

    Diane Fennell
    Web Editor

  • elaine weiss

    I am on Januvia and find it effects my stomach(bloating and uncomfortable)….Has anything been reported about the drug Tradjenta as far as that side effect…..

  • j powell

    Is this drug ever used to treat another condition?

  • Joe nj

    Tradjenta is $15 more than Januiva for a 90 day mail order supply. It seems to even out fasting blood sugar meaning no more wild swings example 130 to 190 more like 140 daily all things being equal

  • William J. Holly, Ph.D. , Philosophy

    Is there some mistake about how much Tradjenta and Januvia lower HbA1C? Twice in the above posts it is said to lower it only by 0.7% !!!!!
    If that is all that it does, it isn’t worth the time it takes to swallow a pill once a day. Do you know what 0.7% comes to? That reads seven tenths of one percent. It isn’t even one percent. Tell me you just do not know how to read decimals.