The biggest thing in diabetes headlines of late is Bydureon, the first and only once-a-week drug to help type 2 diabetics keep their sugars in check, which is newly approved by the FDA. Amylin’s stock price is up, and the pharma blogosphere is all abuzz. But if you’re like us, you may be wondering what the really big deal is. New type 2 drugs come out all the time, don’t they?
Well, for one thing, Amylin Pharmacueticals had to jump through hoops to get this particular GLP-1 injectable drug to market — weathering two previous FDA rejections in 2010 and over 10 years of research and development. Curious, given that Bydureon is essentially the exact same drug as Byetta, its twice-daily injectable drug that stimulates the pancreas to produce more insulin. The difference here is that the core ingredients have been mixed with another compound to extend the effects for an entire week. Because it’s taken only once a week, experts like David Kliff of Diabetic Investor (who’s usually like Mikey – he hates everything!) think Bydureon has the potential to become a “mega blockbuster” and completely change the face of type 2 diabetes care.
“The harsh reality when it comes to managing diabetes is that therapy compliance is by far one of the biggest obstacles to better patient outcomes,” Kliff wrote in a recent newsletter. “This is true not just for injectable therapies like insulin but also for oral medications too… Think for a moment how much easier their lives would be by taking a drug just once a week, a drug that offers solid glucose control, does not require glucose monitoring and comes with added benefit of weight loss.”
Bydureon will certainly be attractive to most patients. In addition to the need to dose just once a week, studies show a significant drop in A1c (averaging between 1.3%-1.9%), weight loss (about six pounds), no increased risk for low blood sugars, and no need for dosing adjustments. Pretty impressive!
Safety & Side Effects
But like all new drugs, Bydureon has its drawbacks. Like its competitor Victoza (a once-daily GLP-1 from Novo Nordisk), Bydureon comes with a Black Box warning for thyroid cancer, because rodent studies showed an increase in thyroid tumors. There’s no data supporting a real risk for this in humans yet, but the FDA still requires the warning based on rodent data.
Amylin is also conducting some post-approval studies to assess whether Bydureon increases the risk for cardiovascular disease, as well as continuing to monitor for thyroid cancer and pancreatitis. But these type of studies are nothing unique to Bydureon.
“When any drug is approved, there are always post-marketing studies (required) to show safety over time,” says David Maggs, Amylin’s VP of Medical Research and Development. “One in question is on thyroid safety. That is something that was called out for Victoza, so we expected it. We’ll be doing a survey to track those details in patients over the long run. It’s a very rare tumor and we don’t believe this will be a significant concern.”
Cardiovascular studies are now something that is required of every new therapeutic drug approved for diabetes. This has been a major sticking point for the FDA recently, in the wake of the huge heart risk debacle with Avandia.
Bydureon’s effectiveness also leaves something to be desired. In Amylin’s own study last year, Victoza beat Bydureon in keeping patients blood sugars in better control. Wow… And here we thought all Pharma studies were skewed. But David Maggs tells us that although Victoza did better in the study, it did so at a price.
“It’s success came at the price of more side effects,” Maggs explains. “There was more nausea and vomiting with Victoza than with Bydureon. Bydureon was a much kinder and gentler treatment for patients in regards to gastrointestinal side effects.”
Interesting, given that Byetta is known for causing nausea and GI issues, and some folks thought these issues might haunt Bydureon.
Clunky Delivery, Cost-Competitive
The unique disadvantage of Bydureon at the moment is that it’s complicated and fussy to take. The process of giving the injection is almost a step backwards in time; patients are required to reconstitute a mixture (mix up powder and liquid) and inject it with a much larger needle than what we’re used to these days — a 23-gauge, 8mm needle, as opposed to the 32 gauge, 4mm needle used for Byetta and Victoza.
For this reason, Amylin has set up a “steady support program” for both patients and healthcare professionals that includes a 24-hour telephone hotline, online interactive tutorials. and even “the opportunity to schedule in-person training sessions with a diabetes educator.”
In their press release, Amylin tried to make it sound simple, stating that “Bydureon is provided in a straightforward single-dose tray so that patients can self-administer…” But those who’ve tried it have a slightly different view.
The Street columnist Nathan Sadeghi-Nejad, describes the process: “Before injecting Bydureon, patients have to connect the vial to the syringe with the adapter, mix the two ingredients, shake vigorously, detach the adapter, attach needle to syringe, pull the viscous drug into syringe, and then, finally, inject. Not so simple, even for experienced diabetic patients.” Sheesh.
TuDiabetes member John Owen-Jones, an Irishman who started taking Bydureon in December because (as always) Europe got it first, describes his experience using Bydureon: “The injection is a bit complicated as its a powder which needs to be mixed with a solvent in a syringe. The needles a little bit bigger than the one with the Byetta pen but still easy enough to inject.”
The other bit of bad news for patients paying out of pocket is that Bydureon will definitely cost more than Byetta, by about $31 per month. On the other hand, it is a good chunk cheaper than competitor Victoza; Bydureon runs $323 for a one-month supply, while a high-dose pack of Victoza costs about $421 per month, according to the Wall St. Journal.
For qualifying patients, Amylin is offering a “Steady Savings Card” to help offset copays; patients can save up to $50 per month on Bydureon prescriptions for up to 24 months. And for those without insurance for prescription drugs, they’ve got a patient assistance program going as well.
Convenience is King
One thing to note: diaTribe reports that a pen injector for Bydureon is in the works and could be expected as early as 2013. Hallelujah!
Because the whole
“paradigm-changer” concept here seems to focus on the convenience factor. In other words, there’s nothing really magical about this new drug versus existing GLP-1′s except the pure convenience factor of taking a drug just once a week rather than every day.
In the words of Chuck Danbury, a 58-year-old patient in the clinical trial, who was previously on Metformin: “This is so much more convenient than anything else… It’s great. I can do (the injection) before I go to work Monday, and I’m done for the week.”
We can’t help wondering how much longer it will take before someone comes up with super-long-lasting insulin that you need to inject just once a week. That would sure as hell be a game-changer for us type 1s, now wouldn’t it?! OK, so I guess we get the big deal about Bydureon.
I was in a test trial by Lily of a product just like this. They ended it 2010 and said that the FDA did not approve it…While on the test trial my blood sugars were consistently 85 to 130. Even when I ate my snickers bar.
I was saddened when it was not approved… I hope this is the same as the trial. I have been fighting with my BS being around 200 ever since I stopped that trial study.
Took my first injection today of Bydureon. Setting up for injection is a little involved, but I was able to mix, assemble and inject all within a couple of minutes. Seeing that this is a once a week treatment it’s no big deal. I’m looking for to the hunger suppressing effect it has more than the blood sugar control. I am getting great control (< 6.0 A1C) with my insulin alone, but found that the Byeta I took really knocked down my hunger cravings. For the first time in my life I actually forgot to eat! My endocrinologist says this new drug is even more effective in that venue.
I have just tried bydureon for the first time just a bit worried as I am on insulin and it states in the information leaflet should not be taken with insulin…. I just hope it works and lose some weight i started putting on with insulin.
My blood sugar is high with Bydureon. I took Victoza and it stayed under 200 no matter what but the thought of just one shot a week sounded great! May not give it two weeks! It has not controlled my blood sugar!
It took at least 2 weeks for BS to come down and now my Dr is not going to add a night time insulin for me because my numbers have improved so much.
I have not been on insulin and was not exciteded to start. Give it a little time you might be surprised! Good luck!
Do not think it works for me, unlike byetta that put you off food altogether bydureon has no effect on me my sugar still the same after two weeks using it.
OK.. JUST STARTED WITH MY FIRST INJECTION OF BYDUREON THIS MORNING. I AM ALSO ON 3 OTHER MED, METFORMIN, AMARYL AND LANTUS AT NIGHT.
AFTER READING THE DO’S AND DON’T ON THE BYDUREON SITE, I AM AFRAID TO TAKE MY LANTUS BEFORE BEDTIME AS IT CLEARLY STATES ON THE SITE NOT TO MIX IT WITH INSULIN. I HAVE A HISTORY OF MY BS DROPPIN TO 40 TO 60 VERY QUICKLY SO IF IM SLEEPING AND THIS HAPPENS.. I’DE CROAK!! HAVE A CALL INTO THE DOC’S AND AM WAITING FOR HER TO CALL ME BACK. IF SHE DOESN’T GET BACK WITH ME I WILL NOT TAKE THE LANTUS TONIGHT AND CHECK MY BS IN THE MORNING TO SEE IF THE BYDUREON KEPT IT GOOD OVERNIGHT. HAVE A HISTORY OF BS RISING HIGHER OVERNIGHT AND THATS WHY THE LANTUS WAS GIVEN ABOUT 4 MONTHS AGO. I’LL KEEP YA POSTED.
OK. THIS IS WEEK 4 ON THIS DRUG. WENT TO ENDO THIS MORNING AND I WAS HAPPY TO FIND OUT I HAD LOST 4 POUNDS! THAT IS MAJOR FOR ME AS I HAVE NO THYROID EITHER SO IT IS MAJORLY HARD FOR ME TO LOOSE WEIGHT. MY SUGAR WAS HIGH AT HER OFFICE THIS MORNING.. 241.. ON AN EMPTY STOMACH WITH ONLY 3 POWDERED CREAM AND 2 EQUALS COFFEES. I HAVE BEEN UNDER ALOT OF STRESS THIS AND LAST WEEK AS MY DEAR PUPPY OF ALMOST 10 YEARS PASSED AWAY.. FROM BELIEVE IT OR NOT DIABETIES! HEWENT INTO KIESODOSIS AND THEY WERE NOT ABLE TO BRING HIS BLOOD GLUCOSE LEVELS DOWN AT ALL. THEY WERE GIVING HIM FAST ACTING INSULIN EVERY HOUR FOR 7 HOURS STRAIGHT AND IT KEPT GOING UP.. SO HIGH IT WOULD NOT EVEN REGISTER ON THE METER.. IT JUST CONSISTENLY SAID HIGH. WHEN I TOOK HIM IN AFTER HIM NOT EATING FOR A DAY IT WAS AT ALMOST 800. SO NEEDLESS TO SAY I HAVE BEEN QUITE EMOTIONAL THE LAST FEW DAYS AND FEEL THIS IS WHY MY SUGARS ARE HIGH. MY EMOTIONS FOR SOME REASON DO EFFECT IT. ALSO JUST COMING OFF A 2 WEEK SINUS INFECTION.. SO ILL SEE HOW TOMORROW GOES.. I HAVE NO SIDE EFFECTS WHAT SO EVER FROM THIS DRUG AND BOY IF I CONTINUE TO LOOSE WEIGHT I WILL BE SO DAMN HAPPY. THE DOCTOR WAS EXCITED TO. I TRULY DONT HAVE AN APPETITE AT ALL AND WHEN I DO EAT I FILL UP PRETTY DANGED FAST. ILL KEEP YOU POSTED. I GO BACK TO ENDO ON 12-18.. AND WILL HAVE AN A1C RUN.. I HOPE IT HAS GONE DOWN.
I am on bydureon 4 weeks now, my bs is running high (225 to 350) all day and night, it is freaking me out. But my dr says it will correct itself though it may take another 3 to 5 weeks for that to happen, he said it needs to build up in ur blood overtime. His biggest reason fr putting me on this was to help me lose weight, no matter what I do I can’t lose anounce, he swears this will help me. When I first started byetta 3 yrs ago I lost 70 lb in 8 weeks. I guess we will see.
I have been on Bydureon for 20 weeks now,I haven’t lost any weight.But my BS #’s are better. I was told by a Nurse Practitioner that the Bydureon is overhauling my metabolic system and to give it 6 months to see any weight loss. It’s also causing constipation. :O
I have pretty good insurance. What is the co-pay on this?
what is co-payment?
I just purchased my 1st RX of Bydueron and was shocked when the pharm. gave me the bill ofo $71.00. My response was “are you kidding? Answer, no, your insurance just paid $ 300 somthing for it. I am on a tight budget and am worried that this chunk of change may be a problem even tho I know Victoza which I’ve read has side effects that sound pretty serious, would mean probably paying even more. I am wondering if a different pharmacy ( I used Walgreens) like Wal-Mart might be cheaper? Maybe I should call them and find out. My MD’s comment when I asked about Victoza was that it was very expensive. I wonder what she would call the Bydueron cost?
From the comments by others on this site, I am going to have to try this out for a month and see if it does make a difference in my A1C or even my daily checks. I was on Byetta and when i moved I decided to ask about the newer drugs. Little did I know that it is the same med. as Byetta only in a different form but requiring a bit more involvement in preparing an injection.
I very much doubt it you will get it for any less i did’nt expect bydureon to be so expensive in UK it is free for us luckily. I personally think byetta is more effective then bydureon.
[...] revealed early this year 2012. For more information on Bydureon, I highly recommend reading Diabetes Mine and David Mendosas take on the new [...]
[...] revealed early this year 2012. For more information on Bydureon, I highly recommend reading Diabetes Mine and David Mendosas take on the new [...]
This stuff is great. I have consistantly better sugars, both morning and during the day. I credit this to acheiving 100% compliance on taking this, as opposed to Byetta, which I would miss whenever I found myself eating out unexpectedly.
The injection process is certainly “clunky” but it’s doable. I’m concerned about the first time I have to be out of town on my injection day. If I have to travel for several days and keep it refrigerated, it’ll add a level of complexity that I don’t need, but we’ll cross that bridge when we come to it.
Waiting for my first A1C…
The product can be unrefrigerated for up to one month… so when you travel, it should be fine until you can get it into a refrigerator later that day. (I found this info in the pamphlets that came with my bydureon kits.)
I have been taking Bydureon for 6 months with good results, however three out of the last four injections I have had problems with not being able to push in the plunger. Tonight I injected myself at least 6 times without being able to deliver a complete dose. I tried changing the needle which did not help. Any suggestions? Am I not mixing it well enough? I give myself injections in my upper thighs, should I try another site? I am at the point of discontinuing use if I can’t resolve this.
Have heard people worrying about keeping Bydureon cold during travel. I remembered reading something about this on p. 6 of the Bydureon booklet that comes with the 4 pac.
Store refrig 36F to 46F
If needed, you can keep your Bydureon tray out of the refrig at 68F to 77F for up to 4 weeks
Protect from light
I don’t know if this is a new addition to the instructions or not, but it seems with reasonable care, traveling shouldn’t be a problem….I had always used just a regular cooler for insulin, but we only travel by car….I guess if you fly things might be different.
I have been taking Byduron for about a week and a half. Have taken 2 injections and my doctor told me that it would take at least a month or so to kick in but it would. I take Lantus one injection in the morning only and also taking Victoza lowest injection and 40 of lantus. As soon as I finish the Victoza I am suppose to stop taking it for about 2 weeks more. Since I got off most of the insulin i was taking i have lost 15 lbs in about 3weeks. my legs would swell up all the time now there are normal insulin does all kinds of things to your body. The mixing part is challenging but I have more poisitive results with this than anything else. My blood sugar is high 199-275 but my doctor is not concerned he told me it would be like that until this buduron took effect.
HERE I AM BACK AGAIN, 5 MONTHS SINCE MY LAST UPDATE. I SEVERLY INJURED MY BACK RIGHT AFTER MY PET PASSED AWAY IN OCTOBER/12 (2 COMPOUND FRACTURE OF 2 DISC’S AND TORE ALL OF THE MUSCLES FRONT AND BACK SURROUNDING MY PELVIC AREA. I WAS LAID UP AT HOME WEARING A BACK BRACE FROM THAT POINT UP UNTIL ABOUT A MONTH AGO. I FINALLY GOT IN TO SEE MY ENDO AND WE WERE BOTH WONDERFULLY SURPRISED. MY A1C FROM SEPT/12 WAS AT 8.9. IT IS NOW RIGHT AT 7, MY CHOLESTERAL IS 194 THE FIRST TIME IN ABOUT 15 YEARS IT HAS BEEN UNDER 200 AND THE BEST OF ALL IS I HAVE LOST 29LBS!! HER WORDS EXACTLY ARE THE BYDUREON IS WORKING THE WAY IT IS SUPOSSED TO BE FOR YOU AND SHE WAS VERY HAPPY ABOUT IT AND SO WAS I. WITH HAVINIG TO BE A SLUG AND SITTING FOR ALMOST 5 MONTHS WITH NO TYPE OF EXERCISE AT ALL I THOUGHT FOR SURE MY WEIGHT WOULD HAVE GONE UP, BUT IN THINKING BACK I HAVE NOTICED THAT I CAN’T HARDLY EAT LESS THAN HALF OF WHAT I USED TO EAT AND I THINK THAT IS WHAT BYDUREON IS HELPING ME TO.. CONTROL MY WEIGHT BETTER. I HAD MY THYROID REMOVED IN FEB/12 AND EVEN PRIOR TO THAT I HAD PROBLEMS CONTROLLING MY WEIGHT DUE TO THE METFORMIN. I JUST COULD NOT LOOSE ANY NO MATTER WHAT AND I HAD A VORATIOUS APPETIE ALONG WITH IT. I QUIT TAKING THE LANTUS MYSELF AT THE END OF OCTOBER AND I NOW TAKE THE METFORMIN TWICE A DAY, THE BYDUREON ONCE A WEEK AND 1 1/2 MGS OF ARMYRL AFTER 2 MEALS A DAY. I CAN ONLY ENCOURAGE ALL OF YOU TO GIVE THE BYDUREAON AT LEAST 6 MONTHS TO START SHOWING YOU SOME RESULTS. I AM VERY PLEASED WITH THIS DRUG, OTHER THE THE 2 OR THREE LUMPS THAT CONSISTENTLY STAY ON MY STOMACH WHICH IS A NON-HARMFULL SIDE EFFECT OF THE SHOT.
I injected my 7 th dose of bydureon this morning. Not only does it not help me to lose weight, it makes me uncontrollably hungry! I was on byetta for almost two years and then it lost its effectiveness. I got down to a normal weight. Size 4 I was thrilled! I tried victoza to no avail, went back to byetta, nothing and then bydureon. I went to dr today and she agreed it just isn’t working for me and I am stopping it and going back to byetta. Hopefully it works again as I have gained 10 pounds without really changing my diet. Anyone experience this hunger on bydureon?
LP..I AM REALLY SORRY YOU ARE HAVING THIS KIND OF REACTION TO BYDUREON. I FIND IT DOES JUST THE OPPOSITE FOR ME. I HAVE TO ALMOST REMIND MYSELF TO EAT AS I HAVE NO APPETITE AT ALL TRULY. IT WAS THE BYETTA THAT DID NOTHING FOR ME EXCEPT MAKE ME SICK TO MY STOMACH THAT WAS IT! ARE YOU MAYBE TAKING METFORMIN AS PART OF YOUR DRUG USAGES. I KNOW THAT MAKES A PERSON HUNGRY AS ALL GET OUT… ESPECIALLY IF ITS A NEW DRUG FOR YOU.
I hope you are feeling better and glad that you are having good results. I am due to take my 9th dose soon. I have not lost any weight and it only suppressed my appetite for a few days. I take spells where I am starving. Dr took me off all other drugs but was having high numbers. I take 1/2 glipizide at night. Now have good morning numbers. Read that since this slows stomach contents from emptying, you need to check 4 hours after meal-not 2 hours. No issue with nausea or injection sites for first 2 shots. Shot #3 introduced major, ceaseless itching and huge welts/discoloration on my stomach. Good think I’m not wearing bikinis! Itching has settled down but still hits at times. My numbers were high at first, then lower, and last 2 weeks going higher again. I go to exercise class 4x a week, am active other days but still struggle to keep from gaining more weight. I am not very compliant with diet, I must confess. Try to stay away from white carbs/sugar. My starting a1c was 7.6. I will post my next a1c result – that will be the true test. Good luck to everyone.
I too have experienced loss of hunger and weight loss while initially on Byetta. This stopped working for me on Byetta. I moved to Bydureon and now get exceptionally hungry usually within an hour after meals. Bydureon is working to control my blood sugar just fine, but I lost the weight controlling effects. My endocronologist just says she is not sure why it works well for some and not others.
I am on metformin, but have been for awhile now. I was on it alongside the byetta and was fine. I know it seems crazy since it is the same drug just delivered differently. I am just hoping the break from byetta will make it effective for me again this time, otherwise my doc said I will just be off everything except metformin.
Congratulations on your success!
I have been on Bydureon over 6 months and have found that my sugar level a1c 5.6. I have lost a few pounds but not as much as my doctor or myself expected being on this drug. I have found the needle when injecting hurts alot. Can a smaller needle be used? I can live with the side effects of lumps on injection site. And what is the best place to inject this drug? It not the same feeling as getting a flu shot as some articles suggest.
judy
I have type II for many years and tried to lose weight for all of them without success. I did control my glucose levels relatively well with two types of Insulin. About 10 weeks ago I saw a TV program about animal produced toxins and how these toxins can be beneficial in medical applications. One of the toxins discussed was the saliva toxins of the Gila Monster and its benefits for Diabetes control. I spoke to my doc. and asked for Bydureon for which he gave me a prescription. I am now in my 9th week on Bydureon with great success. My A1C is now at 6.9 and I have lost 12 pounds from 270! Only 58 to go!!! Two effects I found from taking “Lizard Spit” is the reduced capacity to eat and constipation. The first 4 weeks I had some problems with burping up unprocessed food and acid during my sleep, primarily bread. I changed my food intake times and the problem disappeared. My BS levels throughout the day are now pretty low to the point that I am no longer taking any food time insulin. I did have 4 hypoglycemic sessions early on after starting Bydureon which was rather unpleasant to say the least and I am still very aware that I better have sugar pills with me at all times, especially when I am riding the bike. Having to prepare the shot isn’t a big deal and the thicker needle isn’t all that bad. Some folks here talk like it’s the thickness of a knitting needle. Maybe I have fewer nerve endings or the fact that I inject in my belly blubber
) All I can say is: I am glad to have met the Bydureon “Lizard Spit”. So far it has already changed my life – to the better.