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New Diabetes Drug Approved

By Diane Fennell
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On July 31, the U.S. Food and Drug Administration (FDA) approved the oral diabetes medicine saxagliptin (brand name Onglyza), a joint development of Bristol-Myers Squibb and AstraZeneca. Onglyza will join Januvia as a member of the class of drugs known as DPP-4 inhibitors.

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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.

Onglyza will be offered in 2.5-milligram and 5-milligram doses to be taken once daily, with or without food. It is approved for use alone or in combination with metformin (Glucophage and others), sulfonylureas (DiaBeta, Glynase, Micronase, Glucotrol, Glucotrol XL, Amaryl), or thiazolidinediones (Actos, Avandia) in adults with Type 2 diabetes. Onglyza has not been studied in combination with insulin.

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). The most common side effects seen with the use of Onglyza are upper respiratory tract infection, headache, inflammation of the nasal passages, and urinary tract infection.

For more information about Onglyza, see the press release on the Bristol-Myers Squibb Web site.

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  • Bill Young

    Another new Profit making (hopefully) diabetes drug approved by the FDA! Yaaay!

    Who paid for the clinical trials? By whom were they conducted? How do we know the results were accurately reported?

    How much money is the drug projected to make for Bristol Myers? How long will it be before Onglyza will be pulled from the market when it is inevitably associated with heart attacks, kidney failure and other “side effects?” Hopefully not before its new and improved successor is announced.

    Oh, I forgot to ask, will Onglyza cure Type 2 diabetes?

  • Pat Knipper

    Nothing was stated about type 2 diabetics that take insulin plus oral medication? Can this be used with insulin?

  • Diane Fennell

    Hi Pat,

    Thanks for your comment. As noted, Onglyza has not been studied in combination with insulin.

    Sincerely,
    Diane Fennell
    Web Editor

  • John Jewczyn

    Is this new drug meant to replace Januvia?

  • Don Newman

    I too would like to know who paid for the tests and who approved the test results report. Too often we find after the fact that information about bad side effects were removed from the report to make it sell faster and have doctors prescribe more of it. We need a good type 2 diabetes drug – we just don’t need to die finding one.

  • Laurie

    Bill -should drug companies should quit researching, testing and selling new medications? Progress takes money and I for one am thrilled that my clients have many medication choices to help manage diabetes.
    Sincerely,
    laurie

  • hoolio

    I’m not thirsty at all, even when I exercise but i drink water just to control any dishidration. Is it good or bad for my diabetes ?
    i have some small pains in my legs (they come and go), but i still walk about 1 or 2 hours a day, i do tai-chi 6 days a week, some days i feel tired.
    Should i stop or reduce my walking.
    If this help i take metformin 500mg a day, lisinopril 20mg a day and take herbs and vitamins.
    thank you

  • CyndyC

    I am not sure why no one wants a drug manufacturer to make money. If it is because the drug may be harmful and pushed for selfish reasons, I understand. However, drug companies have lots of employees making money and supporting their families. They also divert money to research to try to make a difference in folks lives.
    If you don’t want to take a medication that is on the market, it is a choice to make. You can tell your doctor not to prescribe.
    I am not a novice, I understand that medications can be rushed through without full investigations. Is that because we want to have medications on the market that make a difference, or is it just greed?

  • bellla forster

    what makes this drug(onglyza) different or more effective than januvia?

  • linda

    how much is that new diabtic med, new meds can be very exspensive even with insurance unless it is a generic
    thanks
    linda

  • Danny

    Bill Young. You’ve posted some very interesting questions here, none of which has been answered, and probably won’t be until more time has passed for an acurate “body count”! However, I think I can answer your last question here:

    “Will Onglyza cure Type 2 diabetes?”

    The key word there is “CURE”! No pharmacutical company will ever develop a “cure” for anything, and especially not for diabeties. Not that they can’t, but moreover because they won’t! Diabeties is a huge cash cow for both doctors and pharmacutical companies, and neither are ever going to jepordize the continuous monetary benefits this desease will bring them.

    Bottom line here, if you are one of the unfortunate to be stricken with diabeties, either the desease itself will eventually kill you, or the side effects of drugs will. It’s a matter of “choose your poison”! The word the medical profession uses is called “Management” not CURE!

  • Jim

    I would like to have you print the trial of how many people were in this trial. How long the trial of this drug took place. What were or was the side effects that took place during the trial. Will this drug interfer with any other diabetic meds. Yes, what about use that take a lot of pills and insulin. PLEASE ANSWER ALL THE ABOVE QUESTIONS FOR ALL OF US.

  • Diane Fennell

    Hi Linda,

    Thank you for your comment. Pricing for Onglyza will be comparable to pricing for Januvia, the other drug currently available in the DPP-4 inhibitor class of medicines.

    Sincerely,
    Diane Fennell
    Web Editor

  • Diane Fennell

    Hi John,

    Thanks for your question. Onglyza is intended to be another option for certain people with Type 2 diabetes, not necessarily a replacement for Januvia. Please speak with your health-care provider if you have any questions about whether one of these drugs might be right for you.

    Sincerely,
    Diane Fennell
    Web Editor

  • Diane Fennell

    Hi Jim,

    Thanks for your questions. According to the press release referenced in the last paragraph, the approval of Onglyza was based on a clinical development program that included 5,000 people, over 4,000 of whom took Onglyza. The drug was studied in people with Type 2 diabetes both as a stand-alone therapy and in combination with metformin (brand name Glucophage and others), the sulfonylurea glyburide (DiaBeta, Micronase, Glynase), and thiazolidinediones (Actos; Avandia). The most common side effects were upper respiratory tract infection, urinary tract infection, and headache. For more information, please click here.

    Thank you for your interest in Diabetes Self-Management.

    Sincerely,
    Diane Fennell
    Web Editor

  • Barbara Briggs

    I have been taking Onglyza now for over a month. I also take Insulin and my glucose numbers are
    much better. I take less Insulin now. I have
    Diabetes 2.
    I do not have side effects with this medication.
    Metformin made me very sick.
    Onglyza is a great product!
    Sincerely,
    Barbara

  • Charlotte Lesser

    I have just had an unusual experience
    My MDswitched me from Actos to Onglyza and after 4 months my blood suger and cholesterol shot up to the point of FEAR
    I’m curious as to whether any on else has had this reaction
    I notice that all the comments are from a previous year with one exception who has had good results with Onglyza
    I DO NOT WANT TO HAVE TO GO ON INSULIN
    I wonder how much Doctors really know.

  • Annie Gilson

    Charlotte:

    I am curious as to why you are so determined not to go on insulin. If I need it,I will use it and have no concerns. My best friend is a Type 1 on a pump…perhaps seeing her cope and live a very normal life has taken away reservations and fear. I was diagnosed as pre-diabetic but have struggled for 6 weeks to control high blood sugar spikes after meals that contained very few carbs. My menu was dwindling to a very meager list of foods, with most fruits and even a lot of veggies off the list. Saw the Endo who immediately looked at data from my meter and said I was not “pre” but diabetic. I am in 1st week on Onglyza and what a difference! I can eat again (lost a lot of weight; beyond what might have been necessary). So far so good. No side effects at all.

  • Saji Jacob

    I am a type 2 Diabetic patient and I was on Metformin for close to a year. I lost about 17 pounds. Due to my weight loss, my PCP changed Metformin to Actos, but I had some complications such as urninary infection and nasal irriatations with Actos as well. Now I an Onglyza and with diet and exercise it works fine on me.
    Good luck

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