New Combination Drug Approved

On November 5, the US Food and Drug Administration (FDA) approved the combination oral diabetes medicine Kombiglyze XR, a joint development of Bristol-Myers Squibb and AstraZeneca, for use in people with Type 2 diabetes. Kombiglyze XR combines saxagliptin (brand name Onglyza), a DPP-4 inhibitor, and extended-release metformin (Glucophage XR and others).


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. Metformin works by decreasing the amount of glucose made by the liver and by improving insulin sensitivity in the liver, muscle, and fat cells.

Kombiglyze XR will be offered in doses of 5 milligrams of saxagliptin/500 milligrams of metformin, 5 milligrams of saxagliptin/1,000 milligrams of metformin, and 2.5 milligrams of saxagliptin/1,000 milligrams of metformin to be taken once daily with food. (The maximum recommended doses are 5 milligrams of saxagliptin and 2,000 milligrams of metformin, respectively.) It is approved for use as an adjunct to diet and exercise in adults with Type 2 diabetes.

This medicine 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), and it has not been studied in combination with insulin. Because of the inclusion of metformin, Kombiglyze XR carries the risk of a rare but serious metabolic complication known as lactic acidosis. Common side effects of this medicine include upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.

For more information about Kombiglyze XR, see the press release on the AstraZeneca Web site.

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  • Rebecca Delio

    I was wondering if you would take this medication with insulin, I have type 2 diabetes and take 70/30 insulin in a pen, I would like to not have to take the insulin.

  • Vicki Mills

    I see no side effects listed. Does anyone know what they are? I looked at the press release and no side effects were mentioned.

  • Vicki Mills

    I see no side effects listed. Anyone know what they might be?

  • Norma Villarente

    I have been taking Onglyza, 5 mgs for about 4 months now. However, it is not combined with metformin. I’m taking Onglyza, 5mg solo and Met500 as solo med. The flyer says The side effect is like Januvia, where an upper respiratory problem may develop.Although I had my flue shot, I have some runny nose now and a little cough even before the 2 freesing nights we had in the Bay Area. So far. I seem to take Onglyza well. I will ask my doctor about this new combined Onglyza,5mg/Met500 medication next time I see my diabetes doctor. It will save me some money from paying 2 separate medicines instead of one.

  • pat

    I am afraid of these new meds. some of them are called back because they do more harm than good.

  • Diane Fennell

    Hi Ms. Mills,

    Thank you for your question. As noted in the fourth paragraph, potential side effects of this medicine include upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.

    Thank you for your interest in Diabetes Self-Management!

    Diane Fennell
    Web Editor

  • pauley

    Is this correct? In paragraph 3 “…and 2.5 milligrams of saxagliptin/5 milligrams of metformin”

  • Diane Fennell

    Hi Ms. Delio,

    Thanks for your question. Kombiglyze XR has not been studied in combination with insulin.

    If you have been prescribed insulin, it is likely that your doctor considers this to be the most effective method of blood glucose management for you. However, you should express your reservations about insulin to him and discuss whether there are other treatment options that might also work well in your case.

    Thank you for your interest in Diabetes Self-Management!

    Diane Fennell
    Web Editor

  • Diane Fennell

    Hi Pauley,

    Thank you for catching that error. I have updated the information in that paragraph to reflect the correct dose, which is 2.5 milligrams of saxagliptin/1,000 milligrams of metformin.

    Thanks for your interest in Diabetes Self-Mangement!

    Diane Fennell
    Web Editor

  • Paul Jackson

    Any information as to the relative merits of this new medication compared to Janumet (Januvia + metformin)? Is it the same, better, weaker? An alternative if Janumet is no longer working as well?

  • Ellie

    If anyone could use a Kombiglyze XR coupon, please go to

    If you are eligible for the Kombiglyze XR coupon, you will pay only $10 a month.

  • ayalew

    I have type II DM and my doctor has prescribed onglyza for me and told me to stop my insulin. I am comfortable in taking insulin but have hypo sometimes when i miss meal. I was wondering if it has more benefit for me to shift from insulin to the new drug. And is it possible to stop taking insulin once you have been on it for years? and doesn’t it have more benefits in protecting from diabetic related complications compared with insulin?

  • phillip

    which of the 2 medicines for type11 diabetes would be better Janumet xr or Kombiglyze xr

  • Peach314

    Is 5mg/1000mg kombiglze stronger than 5 mg saxaglipin, if so, can anyone ESTIMATE by what degree? I would think so obviously, but the physician did not explain, he had an emergency right after handing me the script. My previous physician gave me Metformin as a “test”, I have weak kidneys from a diuretic prescribed 15 years ago for HEARING LOSS, that landed me in a hospital for three weeks. GCS 13; ten years prior to diagnosis. Kombiglze was prescribed by a fill in MD, as my regular MD is on vacation.

  • Watts Tommy

    I am here for the same reason…but my insurance company is dropping Kombiglyze and wants me to take Janumet …Kombiglyze was easy to take, works fantastic and produced zero side effects. I’m not happy either about the insurances claiming to be offering better alternatives…