Byetta Approved for Use With TZDs

The injectable diabetes drug exenatide (brand name Byetta) has now been approved by the U.S. Food and Drug Administration (FDA) for combined use with the class of oral diabetes drugs known as thiazolidinediones.


Byetta, which was approved by the FDA in 2005, was previously indicated as an add-on therapy only for people taking the oral diabetes drug metformin (Glucophage and other names) and/or a drug from the class known as sulfonylureas (including glipizide [Glucotrol, Glucotrol XL], glyburide [DiaBeta, Glynase, Micronase], glimepiride [Amaryl], and the less commonly used chlorpropamide [Diabinese], tolazamide [Tolinase], and tolbutamide [Orinase]).

Thiazolidinediones, also known as “glitazones” or “TZDs,” work by making the body’s tissues more sensitive to insulin and by causing the liver to release less glucose into the bloodstream. The two TZDs currently on the market are pioglitazone (Actos) and rosiglitazone (Avandia).

Byetta, the first in a new class of diabetes drugs called “incretin mimetics,” stimulates insulin secretion when blood glucose levels are elevated.

A clinical trial to test combination treatment with Byetta and TZDs enrolled 233 participants with Type 2 diabetes whose blood glucose levels were not adequately controlled by their oral diabetes medicine regimens (of either a TZD alone or a TZD plus metformin). The study found that 62% of participants who added twice-daily Byetta injections to their oral medicines lowered their HbA1c levels (a measure of blood glucose control over time) to 7% or less over a period of 16 weeks. Only 16% of participants in the group that added placebo injections to its daily medicines did the same. The group that added Byetta also lost more weight than the placebo group (3.3 pounds versus 0.4 pounds) during the same period. The most common side effect of Byetta therapy was nausea, experienced by 40% of participants who received Byetta and 15% of participants who received a placebo injection.

According to a press release from Amylin Pharmaceuticals, Inc., and Eli Lilly and Company, the manufacturers of Byetta, health-care professionals will be educated about this new use for Byetta in the coming weeks.

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  • Mary B.

    I have been using Byetta for a year and a half. Prior to being on Byetta, I could not lose weight. I had been training and running(30 miles a week) half-marathons for 3 years and kept gaining weight(about 12 lbs., not muscle). The doctor had no explanation. I have dropped 19 lbs. since being on Byetta. I wasn’t even exercising for the last year because of some leg injuries, so the weight loss didn’t come from exercise. The only negative that I experienced is that I had to go back down to the 5 mcg dose. The 10 apparently became too strong and was causing worse nausea than when I started it a year before. My A1C’s have been in the 5’s since I started Byetta, even with going back to the lower dosage. I am running again and will watch to see if I have more weight loss and where my A1C stands.

  • AL

    If you want to find out about what Byetta users think check out this and check the Byetta pages
    It has been the greatest help for me

    I have had a 5.1 to a 4.9 A1C on the Byetta and 500ER Metformin for a year now I have also lost 49 lbs.

  • Catherine

    What if a person is very sensitive to drugs? What are the side effects?

  • Levita

    I have been using Byetta now for over a year… I can not say enough good about it… It has been the best thing my Dr has ever put me on… At first I had all the side effects you could ever imagine… But he said ” Don’t give up on me “…. I suffered for many years trying to get my Diabetes under control.. It seemed no matter how hard I worked nothing helped.. I was up to 4 and 6 shots a day of insulin… Taking 96 units of lantis at night plus my oral medicines during the day… Byetta has changed my life…. My doctor also advised me the average weight lost in most cases when starting Byetta has shown to be around 35 lbs…. To this day I have lost going on 70lbs… I do not take any insulins… My A1c levels are down to 6.0 starting at around the 10.0 mark… Anyone that has any questions or is worried about trying new things.. PLEASE give this drug a try… If it helps you as much as it has helped me…. You will be truly blessed…

  • Levita

    (add on)
    The only down side I have found to Byetta is that some insurance companies do not cover Byetta under there perscribtion plan… “BUT” like mine… You can get it covered through the medical part of you insurance after your co-pay is met… AGAIN it is well worth it….

  • Kelly

    After 3 months on this drug, I had to give it up. It made my entire system sluggish, and I found myself feeling ill so often, that much of my usual interest in life was waning. No doubt that it brings down the morning blood sugar readings, which are my particular challenge, but with all the nauseau and general feeling of malaise, I came to the conclusion there must be other treatment options.

  • Theresa

    I have been taking Beytta for 2 months and I am also taking metformin. My blood sugars have come down and I am having good results so far. I have my hba1c taken next month and we will see if it comes down. Thanks for all the information.

  • Cathy

    I have been taking Byetta for over 2 years. It has been a wonder drug for me. In addition to being able to keep my A1c under 7, I have also lost 55 pounds. It is easy to take and the side affects – which were limited to a slight nausea – go away after about the first week. I have also tried Symlin, but had too many lows to stay on it. It wasn’t as easy to take because it isn’t yet in pen form. Jan Chait is right about the needle getting dull from drawing it up from the bottle!

    Bottom line: I would recommend Byetta to anyone.

  • joyce

    I tried Byetta.The first month on the 5mg dose I did fine.My random blood sugars dropped from 180-200 to 110-120 and by fasting dropped from 150’s to 97-115.
    As soon as I started the 2nd month on the 10mg dose I became very ill.Fisrt with severe nausea and then I vomitted 2-4 times daily and had to stop taking the Byetta.
    Of note I had also lost 9 lbs.
    Needless to say I was very disappointed when I had to stop using it,but the nausea and vomitting was too much.

  • Marty

    I’ve been on Byetta for over 2 years. Is it possible for one’s body to become accustomed to Byetta, so that the drug loses its effect?

  • acampbell

    Hi Marty,
    By “become accustomed to Byetta”, do you mean that it no longer is helping to control your blood glucose levels, or have you lost the sense of satiety (fullness), or are you no longer losing weight? Research shows that people can lose the satiety benefit of Byetta after a while; if this is the case, you might try taking your injection 20-60 minutes prior to, rather than right before, your meal. This can also help lower your post-meal glucose levels. Anecdotally, some people have found going off Byetta for a day or two, then going back on, “reawakens” its beneficial effects. However, remember that Byetta isn’t a magic pill in that you still need to focus on lifestyle changes, such as portion control and physical activity, if your goal is to lose weight and/or improve glucose control. Talk to your physician or diabetes educator if you have more questions about Byetta.

  • daniel b

    i would like to know if any one is taking byetta after eatting or does it have to be taking on empty stomach my mother just passed away and i have to take care of a brother who is 100% disable and finding it hard to catch him with out at least a snack in his stomach thanks for any input
    concern little brother

  • acampbell

    Hi daniel b,

    Due to the way Byetta works, it should not be taken after eating. This medication works in several ways, including helping the beta cells to release insulin, decreasing the release of glucagon (a hormone that raises blood glucose) at mealtime, and slowing gastric emptying. The instructions for taking Byetta specifically state that this should be injected anywhere from 0 to 60 minutes before a meal, and definitely not after a meal. However, Byetta is meant to be taken before both the morning and evening meal, so it’s still possible for your brother to take snacks. I’d recommending talking to his physician about Byetta, and asking if it’s still the best choice of medication for him; he or she may suggest a more effective treatment option for your brother, given the change in circumstances.

  • Barb

    Hi Everyone!
    I am so new to the Byetta. However, I want to tell you that I am having some real positives with the useage. I want to also tell the person who posted that the 10 dosage made them so sick that they stopped the Byetta. I too was real ill with the 10; So I went back down to the 5. Just graze. I know that your not really hungry, or feelin much like eating, but if you let yourself get too hungry-or empty. That is when the sickness starts.
    I recommend Byetta to everyone. This has been heaven sent to me.

  • Donna

    I have been taking byetta for about 1 month now. I did notice my clothes fitting better and that my sugar levels are more consistant. I still feel I need to lower my numbers, they are around 130 to 160. I would like them to be in the 97-120 range. I only take 5mg dosage now and was wondering if I should ask my Dr. to up my dosage. I am very pleased with my results so far. What do you all think about asking my Dr. to increasing my dosage? Thanks for any advice you can give.

  • wendy

    I havent seen many current postings but if anyone can tell me about the pen…when is it empty how do you tell my pens seem to be done before the 30 days??? I am doing it right but noticed that they arent lasting the 30 days??

  • joseph griffin

    want to know if any oral form of this med on market

  • peggy

    Does Byetta make everyone have nausea ? If so how long does it last . I can not stand being sick at my stomach . A person I know said he still gets nausea and he’s been on it for three years , but he likes the results he gets .

  • kwades

    Only been on Byetta since Monday (It’s Saturday) and not a lick of nausea. BUT, my blood sugar #’s are looking great! Even better than when I was on Actos…now I’m only on glucophage and Byetta.

    I’m not experiencing the appetite suppressing effects though, maybe when the Dr. moves me up to 10McG next month?? I keep wondering how long until the weight loss kicks in; will it be when the appetite suppression starts or will it be because of the lower blood sugar #’s?

  • jean90

    I am starting Jan 1st, 09 on the first injection of byetta. My A1C has come down to 9 ( was put in hospital in May with A1C of 19!). I am hoping it helps, they put me on insulin and metformin for a while, now off insulin and going onto byetta. Wish me luck.

    I am very happy to read all the success stories, it has helped me with my nervousness about starting this drug.

  • Carole

    I’ve been using Byetta for about 18 months. Too often, I forget to take one a day. In the first 6 months, I could notice a decrease in appetite and some weight loss. After that, there seems to be no appetite effect. Does taking the 2 a day impact on this over the missed one equaling one a day?
    Many thanks.

  • Donna B

    I’d like to know if this drug is available in Canada, and if it’s available in oral form? I’m not on insulin, only Metformin, but I’m gaining weight like crazy no matter how little I eat or how hard I exercise

  • David G

    I have been on Byetta for almost a month now and my numbers have fallen to near perfect levels and my appetite has diminished. I do have slight nausea but it gets better all of the time.

  • Dana G

    I have been taking Byetta for almost 8 months, I have lost almost 36 pounds and feeling great. One thing I have noticed, if I over eat slightly, it does not stay in. Sometimes I have to make myself eat, my A1C’s went from 10 to 6.5

  • maria hancock

    i am 4 metformin and byette 2 daily i have been on byette since christmas and i havent lost any weight this is getting me down can you please help me much appricate your feedback and information

  • lynn

    I have been on Byetta for 8 weeks now, and have lost 33lb. (need to lose total of 84lb) The nausea is quite bad at times, but the weight loss keeps me determined to stick to it. I was also taking gliclazide with it but was getting too many hypos, so yesterday my doctor switched me back to Glucophage slow release. I cannot tolerate standard metformin due to constant diarhoea, glucophage also gave me diarhoea as well but not as bad, so im gonna give it another go.
    Byetta has been a miracle drug for me, for the first time in 6 years my bloods are now at normal levels, and i had given up hope of ever losing weight.

  • Tanya

    I am from Australia, I have been a type 2 diabetic for 8 years now (side affect of PCOS). I am taking 4 x 500mg metformin and have approached my Dr to try Byetta but because he doesn’t know much about the drug he is reluctant to try it also he says it is a tier 3 drug so have to be on 2 other types of drugs before he can put me on it. Is this the case it the US or just the stuid Aussie Dr’s??? Would be interested if anyone knows the guidelines??

  • Marlys

    My doctor wants me to start taking this for weight loss but kind of scared to start…I am a type2 diabetic for 4 years now and need to loss about 30 to 40 lbs. I am taking Metformin and my A1C is at 6. Does anyone have any suggestions or advice?