Januvia is going to eat Byetta’s lunch

Januvia hit our shelves this past week, and I marveled at how inexpensive it was for a brand new drug. (~$300, if dim memory serves.) I think Merck’s going to have a runaway hit on their hands, and Amylin and Lilly are going to be the ones that lose out. I almost feel like I’m stating the obvious here — heck, maybe I am, I haven’t kept with any business news and speculation in several months.

Exenatide (Byetta) is a glucagon-like peptide analog that responds to glucose by stimulating insulin release and inhibiting glucagon release. It also slows gastric emptying, inhibits synthesis of glucagon, and stimulates beta cell neogenesis by preventing beta cell death. It only responds in the presence of glucose, which means there’s low risk for hypoglycemia.

Unfortunately, GLP-1 is broken down by DPP-IV, which limits native GLP-1 half-life to about 90 seconds. GLP-1 is also efficiently cleared by the kidneys. The other downside to Byetta is the fact that it’s injected.

Sitagliptin (Januvia) prevents the breakdown of the body’s own GLP-1 (and other incretin hormones) by inhibiting DPP-IV. As an oral tablet, patient compliance is likely to be higher, or at the very least, it’s more convenient than poking oneself.

Despite having entirely different mechanisms of action, the net effect is the same: higher levels of GLP-1 in the body, with low risk of hypoglycemia. Both Byetta and Januvia are likely to help patients lose weight as well. There’s been some talk about possibly getting Byetta approved as a weight-loss drug — I don’t know how far along this idea is, however.

It’s only a matter of time before we start getting insurance rejections for prior authorizations telling us that the doctor needs to try Januvia before they’ll approve Byetta. This is good news for those seniors on Medicare Part D plans as well — Januvia can save them a pile of money because it’s just so much cheaper than Byetta.

So to recap:

  • Easier to store (no refrigeration)
  • Oral tablet vs injection
  • Once a day dosing instead of twice a day poking
  • Cheaper

I think all the pieces are in place for Merck is going to eat Eli Lilly and Amylin’s lunch here. It seems one investment house is also predicting something similar. (PDF)

38 thoughts on “Januvia is going to eat Byetta’s lunch

  1. That post sounds like from a Merck drug rep – Januvia does not work as well as Byetta and not even as good as metformin. It barely lowers hba1c to FDA rec. levels and has only weight neutral effect and that may be suspect as in the Merck clinical trials while Januvia caused no weight gain, ‘placebo’ pill had some weight loss, so I wonder if there was added exercise and diet in the clinical trials, possibly? Also, byetta lowers weight consistently and continually over time even up to 2 years and beyond as shown in clinical trials. It controls blood sugar comparable to lantus and mixed 70/30 insulins post prandial and has been shown in lab animals to promote beta cell regeneration. And while the drug is injectable, it is a relatively pain free ‘pen needle’ given twice daily, and for many requires less ‘finger pricking’ (which causes more pain) due to better blood sugar control. Also, the company Amylin has a long acting form (LAR Byetta) in late stage clinical trials for a once weekly dosage form which has been shown to work even better and less side effects than the twice daily form. It is not recommended for weight loss in non-diabetics, but their other drug approved Symlin(pramlintide) is in phase II clinical trials for weight loss for non-diabetics, and has been shown to be effective, and is presently approved for type I and II diabetics, and a side effect is weight loss for many. Talk to your doctor for his/her advice.

  2. You know, that’s all well and good. I still like Byetta as a drug, but “better” is a highly subjective term. You’re going to see insurance companies requiring doctors to try Januvia before reaching for the Byetta. I guarantee it. That alone will seriously hurt Amylin and be a boon for Merck.

  3. tell me when I will ‘see’ those cheaper copays for Januvia – as I do want to learn. FYI, I am a pharmacist at a very large pharmacy, and so far, the lowest copay I have seen for Januvia, is within a few bucks from a hundred, and byetta is comparable to most older oral type II drugs and many blood pressure pills, around 30 dollars. You need to do your due diligence, as Januvia is not even top of line for oral treatmentfor T2s, metformin is first line. And just because a drug can be swallowed does not make it most efficacious, or even without side effects. Byetta is not only a better drug, it is a drug that most type II diabetics should at least try, especially if they are overweight and need better blood sugar control, before they end up in worse shape, in need of high insulin doses and then needing toe amputations and losing their vision, and MIs, which is what can happen with continual spikes in blood sugar and having higher than norm hba1c levels. Byetta may not work for everyone of course, and possibly Januvia will help there along with using metformin and possibly other orals and long acting insulin as well. No cure proven yet.

  4. You see to have a vendetta of some kind. I’m not really sure why. I’ve got nothing riding on the success of Byetta or Januvia. You say I read like a Press Release from Merck. I’ve got no connections to Merck. Nor do I have a vested interest in their financial success.

    1) It’s only a matter of time. Januvia is new. It’s less expensive than its closest competition. By a lot.
    2) Byetta will go Prior Authorization for a great many people, with Sitagliptin being the preferred drug to try first.
    3) People like oral medications more than they like injecting themselves, as a rule.
    4) It’s a proven fact that once daily dosing leads to better patient compliance. This is a good thing. (Not that I think Byetta has a high rate of patient non-compliance.)

    And just because a drug can be swallowed does not make it most efficacious, or even without side effects.

    I never said it did. Nor did I imply it.

    Byetta is not only a better drug, it is a drug that most type II diabetics should at least try, especially if they are overweight and need better blood sugar control, before they end up in worse shape, in need of high insulin doses and then needing toe amputations and losing their vision, and MIs, which is what can happen with continual spikes in blood sugar and having higher than norm hba1c levels.

    I am aware of what happens over time, thanks.

    And “better” like I said, is entirely subjective. It’s “better” from a therapeutic outcome point of view. Is it “better” for someone — like my dad — who pays for all of his medications out of pocket?

    Probably not.

    No cure proven yet.

    You don’t say?

    I am merely saying that Januvia’s existence will hurt Amylin and Byetta from a financial point of view. Something you are apparently unwilling or unable to grasp.

    Just watch. It will happen. I’d say within six months. If I’m wrong, I’ll be the first to admit it.

  5. How about an honest comparison between Byetta and Januvia. I was on Byetta and just switched to Januvia because it was in pill form. Should I have stayed on Byetta? Is one better than the other or are they about the same?

  6. If you don’t really know you will know soon enough; If Januvia is truly as ‘equal’ to byetta your blood sugar levels will stay the same or continue to improve and your weight would continue to fall and not gain, and you would continue to feel better and you would not feel like you have to eat a horse at each meal….and I could go on and on, but if you are truly on Januvia I would encourage you to do research on the web and if you are not seeing an endo who really knows the difference, I would encourage you to do so. I have already heard of a couple people that had switched to Januvia, and have already switched back to byetta. Also, what really causes you pain, the pen needle injection of the drug, or the needle pricks necessary for blood sugar tests (even if taking an oral drug)?

    SMT

  7. BYETTA HAS ONE BIG DOWN FALL THOUGH. IT CAUSES NAUSEA IN MOST PEOPLE. I KNOW I TRIED SEVERAL TIMES TO TAKE IT AND I COULDN’T STAND HOW SICK I FELT ON IT. I EVEN VOMITED WITH IT. SO FAR DAY 2 , JANUVIA DROP MY SUGAR FROM 225 TO 189 IN THE AM READING. I’M STICKING WITH JANUVIA.

  8. Januvia has had dramatic results for me. I was taking Avandia, Glipizide, and Metformin with levels still over 200. Januvia (without the Glipizide) has consistently decreased my levels by 50 or more. My average fasting has come down to 120-150. Only problem I had was an interaction with Glipizide (caused rapid heart rate, shortness of breath, panic type symptoms) which I discontinued.

  9. Byetta is working along with 1000mg Metphormine and 4mg of Glimpride.I had the sick symptoms at 5mg but when I increased to 10mg they went away. I didn’t experience weight loss on Byetta wish I did. My doctor says I am the opposite of most people. The shot doesn’t bother me at all staying refridgerated does.

  10. I’m not convinced that Merck is going to eat Lilly’s lunch as you claim; Lilly’s biggest problem in its diabetes business is in a segment the company has long taken for granted: insulin. The company has seen its market share plunge from 82% in 2000 to 43% in 2006 according to data from IMS Health. The market for insulin is mainly patients with type 1 diabetes, a market that has no other therapeutic options. Januvia is irrelevant for that market, and the competitors aren’t Merck, their Novo Nordisk and Sanofi Aventis.

  11. I was taking Metforin and my sugar level had been well controlled. Recently it went up to almost 300 and my doctor changed my Rx to Januvia. I have been taking 100 mg each day for over two weeks with not improvement. The only recent meds change was prescription fish oil which should not have affected my sugar level. Comments?

  12. Generally speaking, one maxes out the biguanide before adding another drug. (Typically you don’t replace metformin with another drug, you simply add to the metformin regimen.)

    But diabetes is a tricky disease, so I’m not really sure.

    And the fish oil is fine.

  13. I have used Byetta to great results both in sugar control and weight loss ( about 18 #)
    the nausa that came at all unexpected times and almost total loss of bowel control prompted me to go back to glucatrol. athe weight did come back slowly 9partly my fault). I am now working to get to Merck’s Januvia, as a retiree of merck I can get their medications free, this is also a consideration. not a primary one at present.
    Byetta’s injection sachedule seems to alyays be in conflict with trying to keep up with life’s demands, the storage of pens in cold and having somewhere to keep them when travel is requires light baggage. The nausa that creeps up and bites one at unexpected times is often a pain. The people I’ve spoken to that were using Byetta seem to have most of the same side effects, some less some worse.

  14. Byetta – no nausea, BG down below 110 from spikes as high as 300. Some sinus aches at times but nothing of consequence or lasting.

  15. I would like to know if Januvia 1/2 tablet with Byetta would help me. I was told to stop Actos 45 because of joint pain and will try Januvia with the Byetta. I feel like Byetta is a good thing I have lost a little weight not much. Any major side effects that you know of?
    yolanda

  16. I have just started taking Januvia samples 8 days ago and I have seen amazing results. My morning numbers have gone from around 138 to around 115 or less. My between meals numbers are now under 95, sometimes in the high 80s. And my 2 hour post meal numbers have been incredible – mostly around 115 or less even after eating (for testing purposes only) pizza, pasta, french toast and raspberry cheese cake. I haven’t tried Byetta, but I can say that Januvia has been great so far. My main worry now is getting my insurance company to approve it, but with these numbers I will fight them tooth and nail if they don’t.

  17. They’re slowly coming around — insurers are realizing that it’s (WAY) cheaper than Byetta, so more of them are getting on the bandwagon.

    This might sound strange, but for a relatively new drug, Januvia isn’t particularly expensive, even when your insurer doesn’t cover it.

  18. I had horrible uncontrolled diabetes on metformin and glipizide alone. I was either too high or too low all the time and felt really bad. I was also wanting to eat everything in sight!
    The byetta really changed my life. In 3 months my A1C went from 9.3 to 6.7 and I lost 20 pounds. I had nausea and heartburn really bad with the byetta both when I started the 5mcg and then 10. My endocrinologist had me take 150mg per day of zantac (available over the counter but check for drug interactions with your pharmacist before taking it) and it stopped the severe indigestion and nausea. Eventually I was able to stop taking the zantac altogether as my body adjusted to the byetta. If you can hang in there long enough, the symptoms go away with time. I currently take metformin, glipizide and byetta, but the glipizide is now the lowest dose you can take- half of a 5mg tablet twice a day. I was on a much higher dose before.

  19. Some folks being put in Byetta along with Metformin deal with PCOS (Polycystic Overian Syndrome)- insulin resistance and are not considered to be diabetic. I am one of these persons who has PCOS, Hypothyroidism and is overweight. I have not filled my Byetta script even though I have been told I would only pay 25.00 a month (not including the needles). I have held off on filling it because I had heard about Januvia. I really do not want to be dealing with an injection if Januvia will give me the same results. FYI, Byetta no longer has to be kept cold from what I have been told. Anyway, is there anyone else out there (those of you posting) who is dealing with PCOS, hypothyroidism and is not diabetic?

  20. I was on Januvia two months ago (samples) for 1 month. Did absolutely NOTHING to my blood sugar (200-300) range. I was also on Metformin. Then, I went off januvia and added glimepiride (8 mg). Blood sugars went down, but still not quite enough. I asked to be put on Byetta. It costs me $35 a month co-pay. I had to cut my glimepiride to 4 mg (and only during the second half of my menstrual cycle…when my sugars are higher) as I go low at night when I stay on the glimepiride with the metformin ER and the Byetta. This drug is a Godsend for me. No weight loss, but I’m not that overweight and so I’m happy just to have good blood sugar control now!

  21. Just wanted to report (see my post from 7/14/2008) that I did try the Januvia and ended up with an allergic recation. If you listen to the TV ads, they talk about rash, hives, swollen face and lips. I had that and ended up have to get a shot to recover. Now I am back to getting the Byetta filled. Still not a big fan of sticking myself, but I will try it. ALERT: If any of you go for a CT Scan, be sure to find out if Metformin should be stopped before the test. I did not know until I finished the test that they require you to avoid your Metformin for 48 hours. Luckily I also had not taken it for a few days prior to the test. I have heard that it is best to avoid medicines prior to tests because they can give false readings.

  22. P.S. The 48 hour wait to take Metformin is after a CT test. I failed to mention this in the post above. I am not sure why their is a wait, but it could be because of the contrast solutions. Thanks all! Caryn from Ohio

  23. I was put on Byetta about 2years ago. Before that my regular MD had me on Glucovance(metformin/glyburide). My blood sugars were all over the place. Even down in the 30’s! My weight was out of control even though I tried to watch what I ate, cutting the carbs and mostly proteins. My hA1C levels looked good, but I felt like crap most of the time because of my sugar swings.

    I decided to go to an endocrinologist for help. There I was put on 1000mg of Metformin(glucophage), Byetta, and Fish Oil. At first 5 and then 10 twice a day. God I was so sick for the first 3 months or so. Never threw up, but the nausea was unbelievable. What keep me going was the weight loss, >30# and I managed to keep it off and still kept loosing. Didn’t mind the injection, but keeping the Byetta refrigerated and with me working out of town, proved a hassle. Always thought that a single (throw away) dose would be perfect for those situations.

    Then, all of a sudden, I started throwing up, without rhyme or reason. Just started feeling bad, tired, no energy, and an aversion to food. My endocrinologist thought I was beginning to show symptoms of pancreatitis and did the blood work to verify. I was taking off the Byetta and given Januvia, (100). Also, my test revealed that my Vitamin D was extremely low, even though I include a multivitamin with Vitamin D in my daily pill regime.

    Must say that I feel better. My appetite has become better, but I don’t seem to overeat. Haven’t been on the scales yet, but my concern is weight gain. Blood sugars seem good, average around 125-130, even in the morning, where I use to have problems with my liver putting out to much sugar overnight. I’ll stay on Januvia as long as it seems to work and there’s no weight gain.

  24. have been on januvia for about 2 months – along with 1000 ml of metformin daily (no problems with insurance copay) BUT terrible problem with flatulence – morning, night, all day no matter what I eat or if I eat.

  25. I tried Byetta and it worked great as a weight loss medicine. the only problem is it made me sick. Several times I had to get out of the car and upchuck. I liked the lose in weight but it didn’t beat the sickness. I now use juniva and it is working pretty good.

  26. I have recently been diagnosed with Type II diabetes. My doctor prescribed Metformin which I took as directed. Within 4 days I began have sever diahrreah (with a lot of blood) and stomach cramps. Of course, I called my Dr. immediately and was told to stop taking it. I’m wondering if these side effects would go away if I continued on the Metformin.

  27. I’ve been taking Byetta for over a year now, (a “10” dose in the morning, a “10” dose before dinner, and a “5” dose at bedtime). I have been taking it in conjunction with glucophage xr (metformin): 1500 mg daily. While my blood sugars are improved, I’ve lost NO weight on Byetta, despite a carefully tracked 1200 calorie per day, 30% carb nutrition plan which is implemented at 5 mini meals a day, 2 hours of ZUMBA a week, 2 hours of cardio kickboxing a week, 2 hours of weight training a week, and 3 hours of Iyengar yoga a week (I am the instructor for the latter). I have had my BMR calculated for baseline purposes, and my bodyfat by electrical impedence. Since using Byetta, I’ve gained body fat and lost lean muscle. Go figure.

    My endo put me on Janumet today…. one tab (50/500)to be taken with dinner. I’m still to take the Byetta and glucophage xr. Ignorant as this sounds, I could give a rip if it lowers my postprandial BG readings (they’re already fairly controled on the byetta and metformin alone). I am seriously needing and wanting to lose fat. If Janumet/Januvia does the trick, then I”ll be one happy T2!

  28. I am taking Januvia, but I have only recently begun restricting my calorie intake. I do not want injections (Byetta), so I’m becoming more serious about my current regimen: Januvia and Glucophage. The generic (Glucophage) gives me stomach pains. I have no problems with Januvia.

  29. After being diagnosed with Type 2 Diabetes, I was put on METFORMIN. It worked really well decreasing my blood sugar, but I developed severe, debilitating diarrhea.

    I have now been using BYETTA for a few months, with an increase in the dose, and it has done nothing for me except make me feel full all the time. Blood sugar numbers have not decreased; neither has my weight.

    I’m going to ask my MD about JANUVIA, since it works in a different way. It reduces the destruction of GLP-1 (Glucagon-Like Peptide 1) which plays a critical role in pancreatic function and the regulation of blood sugar levels. I understand there are studies going on right now to find medications (TGR5 activator: INT-77) that will INCREASE GLP-1, with the great side effect of increasing cellular energy and reducing fat mass and obesity as well as blood sugar. I hope this is not too long a time coming. It makes a lot of sense to me.

    I am a holistic health educator. I think everyone should remember there is no single panacea for everyone. Everybody is different, and there are complex metabolic processes going on in the body. Sometimes lifestyle changes help alone. Sometimes you need a pill or an injection to help. I am still looking for answers for myself!

    I wish you health and happiness.

    Dezi

  30. Byetta is made from a component of Gila monster venom. As for as I know this component has not been fully synthesized in the lab. Even when synthesis takes place—-there is always a chance that one atom will not be in the right place and we end up with an analog that is not the drug we expected. For those who know nothing about organic chemistry —is is like we are ending up with a gray ball when we were aiming and wanted a white ball. It could be that the reason one gets sick is that they are getting something else along with the needed component when the drug is made from natural venom–that is the drug that they are taking is contaminated with other parts of the venom.

    Byetta promises many good things—when the Gila Monster eats–its blood sugar levels stay on keel and does not wander all over the place. This makes the venom component a very good drug for diabetics. Its downside is that it does make some folks nauseated and it must be injected. These side effects are very acceptable compared to the side effects of Avandia which can and has killed people by causing cardiological problems. Avandia is now off the market but it would be nice if we could have an oral drug that works like Byetta with minimum side effects.

  31. When I am diagnose with Type 2, its pretty serious. So metformin doesn't work much. Other drugs diamicron mr + avandia + metformin = I increase significant weight 10kg in 3 months period.

    They now change me to Januvia + metformin. Hopefully will get better. The doc was talking to me about Byetta as well but its not covered. So if I change to that its going to be pricey. I decided to stick with januvia for few months and see if it helps

  32. Byetta has turned my health aroung 100%. No reason at all to risk that on a new drug! Thank you to my Dr. I have a brand new outlook on life. D.C. Mtn. Home, Ar.

  33. I haven’t seen the Medicare donut hole concerns addressed. Using the 10 mcg dose twice a day costs me & Medicare approx $300 per month & puts me in the D-hole (along with all my other meds) at between a half to 3 quarters of the way thru the year. I can easily manage the costs of my other meds, but Byetta is the back breaker. And checking with my pharmacist, Januvia was not less expensisve. I contacted Amylin directly but they were not able to help…………….I am looking for alternatives to spending the rest (I’m 66) of my life just living to pay for meds that will allow me to keep on living. What’s the point in that kind of struggle? When do my golden years start?

  34. Too bad that Januvia has shown to increase the risk of melanomas, because of the suppression of the immune system, and the crock that Januvia can make Beta cells rejuvenate,is untrue. The drug manufacturers are once again pushing Dr’s to push these drugs on their patients. Control your Diabetes with Januvia, and risk deadly melanoma. Guess we just can’t win!

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