August 3, 2009

Onglyza: Just Like Januvia but with More Serious Side Effects?

NOTE (April 2, 2013): Before you take Onglyza or Januvia please read about the new research that shows that they, and probably all incretin drugs, cause severely abnormal cell growth in the pancreas and precancerous tumors. You'll find that information HERE.

When the FDA approves a new drug it requires no proof that the drug is more effective than similar, existing drugs, only that it is better than placebo. Which is something to keep in mind as Bristol-Myers Squibb unveils what is sure to be a saturation advertising campaign for its new DPP-4 inhibitor, Onlgyza.

This mellifluous moniker is the brand name for Saxagliptin, which alert followers of drug news remember as the Januvia clone developed at the same times as Januvia whose release has been blocked due to its ability to cause "skin lesions" some of which necrotized (i.e. died and fell off) in monkeys.

I have read through the Prescribing Information for Onglyza and cannot see any benefit it offers in comparison to Januvia, the other DPP-4 inhibitor currently on the market.

Setting aside for the time being the advisability of controlling your blood sugar by turning off a tumor suppressor gene Onglyza offers nothing not offered by Januvia.

Both inhibit the expression of the DPP-4 gene for a full 24 hours--which means that if your body was fighting a new, very small DPP-4 sensitive tumor, like ovarian cancer, melanoma, prostate cancer or lung cancer, the drug would keep DPP-4 from killing off the tumor cells.

1. Feeble impact on blood sugar: Onglyza lowered A1cs that averaged 8% by .5%, which does not bring them anywhere near a safe level even by the anemic standards of the ADA. When the highest dose of Onglyza was compared to a placebo, it allowed only 14% more of those taking it to achieve 7% A1cs.

To better understand how "Effective" it is, consider what that A1c really meant: Onglyza lowered the average fasting glucose in those who took it from 171 mg/dl to 162 mg/dl (9.5 mmol/L) to 162 mg/dl (9 mmol/L). It lowered the average two hour post-meal blood sugar reading from a damaging 278 mg/dl (15.4 mmol/L) to an equally complication-guaranteeing 235 mg/dl (13 mmol/L).

So my immediate question would be: Why take this drug which is likely to cost 3 or 4 dollars a day to "achieve" blood sugars that are still high enough to lead to amputation, blindness and kidney failure when for the same money or less you could use insulin to get normal blood sugars?

2. Negative impact on the immune system. Inhibiting the DPP-4 gene, which produces an enzyme that rids the body of GLP-1 by chopping it up, lowers blood sugar because GLP-1 lowers blood sugar. However DPP-4 is used by the immune system for other functions most doctors know nothing about. Januvia's initial testing showed that it caused changes in white blood cell counts which the drug company dismissed as being of unknown significance.

Onglyza has a stronger impact on your immune system's white blood cells. In the prescribing information we read:
There was a dose-related mean decrease in absolute lymphocyte count observed with ONGLYZA. From a baseline mean absolute lymphocyte count of approximately 2200 cells/microL, mean decreases of approximately 100 and 120 cells/microL with ONGLYZA 5 mg and 10 mg, respectively, relative to placebo were observed at 24 weeks in a pooled analysis of five placebo-controlled clinical studies. Similar effects were observed when ONGLYZA 5 mg was given in initial combination with metformin compared to metformin alone. There was no difference observed for ONGLYZA 2.5 mg relative to placebo. The proportion of patients who were reported to have a lymphocyte count ≤750 cells/microL was 0.5%, 1.5%, 1.4%, and 0.4% in the saxagliptin 2.5 mg, 5 mg, 10 mg, and placebo groups, respectively. In most patients, recurrence was not observed with repeated exposure to ONGLYZA although some patients had recurrent decreases upon rechallenge that led to discontinuation of ONGLYZA.


Translated into English, this means than in 1 person in 100 who take it, Onglyza lowers the white blood count to a dangerously low level.

If your doctor prescribes Onglyza without requiring that you have a blood count periodically, you can be sure the doctor has not read the prescribing information. Few doctors do.

3. Onglyza conflicts with common drugs and grapefruit juice Because of the way it is removed from the body Onglyza may build up in the blood stream when taken with common yeast medication, ketoconazole, as well as with erythromycin, calcium channel blocker verapamil, and grapefruit juice. Onglyza levels also rise in people with poorly functioning kidneys. The manufacturer says that dose must be cut back in people using these drugs. Whether busy doctors will know this and warn patients about lowering the dose when needed is another story.

4. Onglyza raises the peak Concentration of Sulfonylureas and TZDs. This makes it more likely people whose doctors prescribe this new drug with a sulfonylurea drug will experience hypos. Onglyza also reduces the peak concentration of metformin.

5.Side effects The main side effects reported with Onglyza are the headache and runny nose that are also found with Januvia and which result from the inhibition of the immune system these drugs cause. Over time, my experience with taking Januvia for several months was that the headaches increased in intensity in a way that made me glad to stop taking the drug.

However, Onglyza also causes other immune reactions: As reported, "Hypersensitivity-related events, such as urticaria [rash] and facial edema [swelling] in the 5-study pooled analysis up to Week 24 were reported in 1.5%, 1.5%, and 0.4% of patients."

Januvia also turns out to cause rashes, including, very rarely, the life threatening Stevens-Johnson syndrome where people's skin peels off the body. It is significant, though that rash did not appear as a side effect of Januvia until after the approval testing was complete. That Onglyza produced such a high rate of rash during testing seems to suggest that it has a higher potential to disrupt the immune system.

6. No evidence that this or any other DPP-4 inhibitor preserves beta cells I mention this because the drug reps are selling these drugs to doctors claiming, based on weak animal evidence that these drugs preserve beta cells. No drug can preserve or regenerate beta cells when blood sugars are rising over 140 mg/dl for long periods of time, because sustained high blood sugars cause glucotoxicity--poisoning of beta cells. With the many years that BMS has been testing Onglyza you can be sure they have run every test they could find to demonstrate beta cell preservation and the complete lack of any cite to this in the prescribing information suggests they could not find it.

Why Take Onglyza?

Nothing in the prescribing information suggests any advantage in taking Onglyza compared to Januvia, while at the same time suggesting strongly that Onzglya's impact on the immune system is stronger than Januvia's. No research was done into whether Onglyza increases the incidence of tumors in those who take it, and because of the very small numbers involved in the clinical trials and the way the drug companies bury tumor incidence (combining benign and cancerous tumors in one category, as in the Januvia trials), that data is not likely to emerge.

Nevertheless, I'm sure a BMS drug rep is hard at work motivating doctors to switch patients to their new drug. Don't be surprised if your doctor suggests you enroll in a "study" using Onglyza, as this is a common way to divert patients from an existing drug. The "study" will provide you with one or two month's free supply of the drug because the companies know that once you are used to taking it you are likely to continue taking it. You'll be seeing free samples and eventually saturation advertising on diabetes web sites and TV.

The really sad part is that the net effect of all this will be only that patients with A1cs of 8% whose fasting blood sugar is well over 150 mg/dl and whose post meal blood sugars are in the range the ADA long ago defined as causing blindness (over 200 mg/dl two hours after eating) will take another expensive drug that ensures they won't get the kind of control that prevents the classic complications.

If you have blood sugars that high before you pay a couple hundred bucks a month for a potentially harmful new drug try the following:

1. Try the technique described here: How to Get Your Blood Sugar Under Control. It really works. Even for people who have had diabetes for as long as a decade.

2. Add extended release metformin if you can tolerate it and have no kidney or liver problems. Metformin is much more effective and less prone to cause digestive distress when used along with a diet lower in carbohydrate.

3. If cutting back on the carbs in your meals and adding metformin doesn't lower your blood sugar to safe levels (Under 140 mg/dl after eating) demand that your doctor send you to an endocrinologist so that you can get a tailored insulin regimen that gives you normal blood sugars.

Do not settle for the kind of insulin regimen family doctors usually prescribe which almost always leave you with blood sugars that are damagingly high. These inadequate insulin regimens are designed to keep your blood sugar high so as to avoid hypos--and to avoid the need to give you the kind of diabetes education routinely offered people with Type 1. With proper diabetes education you can avoid hypos and get great control. But for most Type 2s, to get the right kind of insulin regimen prescribed you will have to find a young, knowledgeable endocrinologist who will take the time to work with you on tuning your insulin regimen.

If your doctor won't help you get normal blood sugars, and insists that all you need are oral drugs fire him or her and find one who will give you the help you need.

Every person with diabetes can achieve normal blood sugars and normal blood sugars produce normal health.

40 comments:

Scott said...

The only apparemt victory in approving this drug (aside from the drug company's shareholders) appears to be bringing some potential competition for Merck's Januvia. Patients, however, should beware that the newest (even with the FDA "seal of approval") doesn't mean much in today's "science for sale" environment. If it sounds too good to be true, chances are, it probably IS!

reyna_simon said...

I"m a scientist in the field of diabetes and I don't have any feeling one way or the other about Onglyza. I do want to correct something you said, "Setting aside for the time being the advisability of controlling your blood sugar by turning off a tumor suppressor gene Onglyza..." DPP-IV inhibitors do not turn of tumor suppressor genes. They inhibit a processing protein that processes one of the players in insulin secretion and by inhibiting this enzyme, you end up increasing glucose-dependent insulin secretion, and that's a good thing. I hope this is helpful.

Jenny said...

Reyna-Simon,

Sorry, but you are wrong. DPP-4 which is a protease coded for by the gene of the same name does of course cleave GLP-1, but it also appears to function elsewhere in the body as a tumor suppressor, most notably for s melanoma. I have checked out that the identity of DPP-4 is the same in both situations several scientists who have researched the functions of DPP-4 including its anit tumor activity. These scientists have confirmed that the tumor effects of DPP-4 are significant and that inhibiting DPP-4 might promote cancers. They have also told me that no research has been done to investigate the impact of these drugs on cancer. One researcher told me that reversible inhibition for a few hours would probably be safe, but not 24 hour inhibition.

The research linking DPP-4 with tumor suppression is documented with citations to the relevant research HERE.

It is unfortunate that scientists in the diabetes field seem to have completely ignored the other uses of DPP-4 in the body. The sinus headach side effect, for example, is a byproduct of yet another use for DPP-4.

For the sceptics, I would like to note that I posted a warning about Macular Edema and Avandia and about osteoporosis and Avandia several years before the medical press picked these stories up. I also wrote about the TZD's ability to cause heart failure long before it hit the media.

The DPP-4 cancer connection has been cited in Annals of Internal Medicine, in a communication from Dr. Goldstein.

mathew said...

I feel that since Onglyza doesnt have any upperhand on efficacy level vs Januvia, onglyza will struggle to click to overcome the barrior of immune side effects.

skitzmann said...

I have been using ONGLYZA for over two weeks and have found that the drug has done something I couldn't do and that is wake up to a blood count of 90-120 where it had been 135-160.
I have been experiencing one thing and that is I have a light headedness during the day. This feels like Low Blood (LB) but it dosen't send me into the 50 to 80 range and I can still function. I have a small concern with that and will see my doctor on the 16th of August. Just posting to find if there has been anyone with that sympton.
Thanks.

wise doc said...

is it possible that Onglyza is causing a curiously oversensitive gums and more importantly teeth soreness in the mornings?

It certainly is not gingival hyperplasia or gingivitis but very very painful teeth in the mornings which get better as the day wears on.

A couple of my patients have reported this.There is no other common link of medications that they are on.

Jenny said...

Wise Doc,

Tooth pain was reported by several early adopters on the old Byetta blog, so it is possible that this is a GLP-1 related issue.

Or it might have to do with the same genetic issue that causes the sinus headaches, which has to do with Januvia changing the way a gene found in that tissue expresses.

I hope you will report this to the FDA's Medwatch as that is the only way they find out the real side effect profile of these new drugs. The manufacturers don't report any more than they are forced to.

Often these trivial seeming side effects, like edema with Avandia, hint at more subtle and damaging changes going on whose toll won't be clear for a decade.

Stan Kitzmann said...

I have been using Onglyza now for 45 days and am amazed in the drop of morning blood test. It was constanly in the 140 to 170 range and now it never goes over 140 and is often around the 110 to 125 range. I do notice one thing is that I am light headness in the day time. I take mine about 8:00am in the morning.

ejamescook1 said...

A diabetic for over 30 years and not able to tolerate any diabetes drugs except Glipizide. Have tried them all including Januvia and insulin with poor results and terrible side effects. Recently tried Onglyza as A1/C at 9.1 - 10.2 ramge. From day one BS readings dropped from the 200+ range to the very loww 100's and have stayed there. Yes I get the headaches, but this is the first and only medication that has ever worked for me. I guess there are other risks, but that is true for all drugs.

Joseph said...

If you take Coumadin or another blood thinner you should never take Onglyza. It has a dramatically adverse effect on your Coumadin levels and the Coumadin seems to destroy any positive effect the Onglyza has on blood sugar levels. After a month on Onglyza, with no other changes in diet or medication, my Coumadin levels were at historic lows. 2 weeks after stopping Onglyza the Coumadin level was back to normal and blood sugar was improved.

Stan Kitzmann said...

I am wondering where the info came against ONGLYZA. I have been taking the drug now for 3 months and have had great the sugar readings. The best I ever have had. I went off the drug in December of 2010 due to the DONUT hole and my sugar levels shot right back up 140 to 160 after fasting from 8 to 9 hours of sleep. Every time I hear someone with TYPE 2, I suggest ONGLYZA.

Jenny said...

Stan,

The information about Onglyza posted here is all documented in great detail if you follow the links. It comes from the FDA mandated prescribing information and from the research about the other effects of DPP-4 in the body which raise questions about what happens when you stop it from working.

No one is saying it doesn't lower blood sugar. What the problems are is that drugs that inhibit DDP-4 also do other things that take some time to show up, including turning off your ability to fight infection (recently documented in a study I will be blogging about soon) and turning off one of the mechanisms your body uses to fight cancer.

It takes years for these effects to show up, but the acceptance testing for these drugs only lasts about a year and a half--not long enough for the long term problems to show up.

Shanon Allen said...

I take onglyza, I have notice that my hair is falling out from the root is this a side effect .

Jenny said...

Shannon, Since this is a brand new drug and since the tests for its approval were run by the company with a relatively small number of people, it's impossible to know if something IS a side effect.

Eventually when millions of people take it, the side effects emerge, but even then, something mild like hair loss isn't likely to be reported.

Tell your doctor about it. Hair loss can sometimes be a symptom of thyroid dysfunction.

Marcy Brennan said...

I've been on metformin first 500 mg twice a day to now 1000 mg twice a day, and I have chronic, debilitating diarrehea that controls my life. I still have between 120-130 reading first thing in the morning. Doc gave me 2 mo of onglyza samples yesterday. When I asked about side effects, he said not really anything significant. Well I'm sure thankful for the Internet! Would insulin be preferable to metformin, onglyza and januvia (which, by the way, is what he was telling me to take and when I asked for samples he gave me the onglyza).

Jenny said...

Most doctors assume patients will do anything to avoid insulin so they don't suggest it. Plus it takes time to educate patients how to dose insulin.

But if you tell yours you'd rather take insulin than new drugs with troubling side effects listed and many others that aren't yet known because they are so new, perhaps you can try it and draw your own conclusions.

Doctors tend to brush off the side effects listed in FDA prescribing information, and I did too, until I developed a permanent, serious side effect, listed in the PI of a drug my doctor had prescribed, and when the side effect emerged, told me to ignore. Now I know I'm the one who will suffer the side effect, not the doctor, and I'm more aggressive about researching drugs and refusing ones where the risks outweigh the benefits.

If the doctor tells you that the other drugs regenerate your beta cells--a line the drug reps use to sell them--you will have to tell him there is no evidence of that from any human studies.

johnette coe said...

at Jenny.
I have been on Onglyza for over 2 years now,,, no hair falling out, no skin problems, and for the first time I didnt get sick the first year I used it.. felt great after I started taking it, the only time I have felt bad is when my new dr changed my asthma meds and when he took me off recently to see if I can do it on my own.. thinking Im ready to go back on I like the way I feel on it( hated the metformin)

Malek Nahar said...

I have noticed that you are suffering from companies and "med reps" as i've seen many comments VS them

Im a DPP4 inhibitor med rep, our company and me myself have never promoted the "regeneration Of B cell" issue, we promote that our product "Preserve" and yes we have trial

My advise for you and for your followers, is to report any company's promotional activities of non-existable feature benifit or indication, such actions are strictly prohibited and considers as clear violation for Pharmaceutical code of conduct-Ethics.

Regards

Malek Nahar said...

Ejamescook
Hi
You've been diagnosed as T2D For 30 years, and Onglyza was that effective as You have described?? Im wondering about the medical status in your country guys!

There is no DPP4 inhibitor on earth can be effective if the patient's history of diagnosis is longer than 8-10 years ! And that because there will be no B cells in Pancereas

Jenny said...

Malek,

Plenty of people with Type 2 diagnoses still have significant beta cell presence 8-10 years after diagnosis, especially if they have controlled their blood sugar to normal or near-normal levels. I sure do after 14 years.

Malek Nahar said...

Jenny,

It depends on the way they have followed to achieve being normal or near normal phases, if there is SU in the regimen, B cells will not last longer than 7 years...
Considering 27% of T2D patients are controlled or near to, 90% out of this 27% are on SU, So that plenty sounds like 5% of T2D patients

Jenny said...

Malek,

Actually, long term studies do not confirm the idea, mentioned by Dr. Bernstein, that sulfonylureas burn out beta cells. Decrease in insulin production is identical in UKPDS between those taking metformin and those taking sulfs.

In addition, another study has found that the drop in insulin often observed after long term sulf use is not due to destruction of cells and is reversible with a drug holiday.

That said, all but 1 sulf seems to be bad for the heart, and that one isn't sold in the US. Prandin, which uses a similar mechanism is also a safe beta cell stimulator.

Details at http://www.phlaunt.com/diabetes/25311847.php

TJ said...

I take 13 units of Lantus insulin once a day. Also with that I take 1000mg of metformin and glipizide. Then in the mornings before I go to bed I would take the Metformin and the glipizide pills only. After a year that wasnt working, so My Dr. added 5mg. of Onglyza once a day with the Insulin shot and the other 2 pills. Well It may help some but what I have noticed even more is I have gained 10 lbs. in a month and seem to be hungry and have the munchies ALL the time!! Where as before, I didnt have the hunger like now. In fact I was losing weight gradually. But maybe that was due to high blood sugar levels?? If anybody knows anything about the weight gain side effect or if its just me, Please let me know.

Thanks

Tim

Jenny said...

Tim, Glipizide in conjunction with other drugs will do what you describe. Please read the page linked at the top of this post to learn why Onglyza may be dangerous.

Try the technique you will find at http://bloodsugar101.com/how.php . It is surprisingly effective.

C said...

I am type 2 now 8 years taking Metformin and Gjyburide and after uncontrolled BG's for sometime and having no family doctor available to me I saw a walk-in clinic doctor and started basal/bolus insulin therapy last month. Having no help, I had to learn dosing on my own. After only a month on insulin of the three month test period my A1C dropped from 9% to 8%.

For reasons I don't understand an endocrinologist who I saw after starting insulin prescribed Onglyza as well saying it would help lower my A1C. After researching on the internet and reading comments here I do not see the purpose of using this drug. My Lantus SoloSTAR insulin pen takes care of my overnight fasting with morning BG's between 4.0 and 5.5 mmol and my NovoRapid FlexTouch insulin pen takes care of the mealtime spikes with BG's between 6 and 8 mmol. I am pretty sure my next A1C will have me at 7% or less without taking a drug that I do not trust or appear to even need, in fact increased hypos is a stated side effect if insulin is being used as well.

For me, starting insulin was not a big deal with the convenience of insulin pens and 3 or 4 injections a day (I do not always eat 3 meals a day)is not a problem. If I am eating in a restaurant no need to use the restroom, I just quickly inject in my upper arm right at the table. I may for even better BG control and added convenience even look into an insulin pump as my insurance will cover 2/3 cost on the pump and 100% on supplies for type 2 diabetics.

Jenny said...

Given that solid data now supports the finding that Onglyza is likely to cause the growth of tumors in the pancreas and create abnormal beta cells growing in abnormal patterns there is NO reason to use Onglyza except to enrich the company that makes it, as it is very expensive. Details HERE.

Doctors have been brainwashed by the drug companies and prescribe whatever is newest no matter how untested or potentially dangerous.

C said...

Jenny, Thanks for the info, I have sent my endocrinologist the link to the study. Do you think that (for whatever the cause) the increased production of Glucagon is a factor in type 2's having to go on insulin therapy and experiencing increased insulin resistance?

Jenny said...

Abnormalities of glucagon production cause type 2 in some people quite independent of taking any drug. At this point we don't know enough about what these drugs do to know what that additional glucagon does. The tumors and abnormal cells worry me the most.

Doctors should be demanding more research. Sadly the drug industry has sent out highly paid influential doctors and PR people to tell the media and doctors that they should ignore this study. They give no cogent arguments, nor do they disclose how much the drug companies pay them to sway opinion. They just say things like, "I'm so sure this drug is safe, I'd give this drug to my mom."

The recent article in the New York Times was a classic case. The writer extensively quoted drug company flacks and a guy from the ADA (a massive beneficiary of drug company money) neither of whom are researchers, while giving almost no coverage of the researchers who argued this was an extremely important finding.

A lot of people will suffer needlessly so that the drug companies can stay profitable.

C said...

Now on basal/bolus insulin for 6 weeks my A1C test came back at 6.2%, down from 8.1% in just a month. My A1C will be tested again in a month while on insulin for 10 weeks and hope to see a improvement again.

C said...

My recent blood work came back with a A1C of 5.4%. That is down from an initial A1C of 9.5% after being on Metformin and Basal/Bolus insulin therapy for 10 weeks. Being very insulin resistant I was using 150 units (75 twice a day) of Lantus and 1 unit per carb consumed of NovoRapid for, depending on meals, up to 200 units of the rapid insulin a day. However this allowed me to achieve good BG control.

Strange thing that happened to me was I took my 60 units of NovoRapid after a 60 carb dinner and 4 hours later took 20 more for a snack and 2 hours later took my Lantus as has been my normal dosage routine for two months now. I woke up about 1:00 AM in the worst hypo I have ever experienced. I was so unstable I could not even test. I immediately ate 4 Lifesaver candies followed by another 4 and after about 20 minutes felt well enough to test. At that point I was at 2.9 mmol. I ate another 4 candies and finally pulled my BG over 4 mmol and went back to sleep. Somehow my pancreas had produced enough insulin to make my injected insulin overdose me.

The next day I cut back my insulin taking no Lantus and only 1 unit per 3 carbs of NovoRapid. Even this reduction had me in the low 3 mmol range for the day. I had a very high carb dessert that night taking no insulin to pull me out of this low sugar state and after 2 hours had my BG up to 4.7 mmol. Again I took no Lantus going to bed and woke up the next day with a fasting BG of 5.2 mmol and went the rest of the day taking only my Metformin and no insulin at all and have for the past few days now have maintained BG,s of between 5 and 7 mmol.

Has anyone ever heard of this happening to someone who had very poor BG control for nearly 2 years when oral medication was not working well anymore but then had excellent BG control for 2 1/2 months?

Jenny said...

C,

This isn't the right place to discuss the important issue you raise. I would suggest you post on one of the diabetes discussion forums where you can get a response from many people. This comment stream is only read by people looking for information about the oral drug Onglyza.

But I will say that when you normalize control with insulin it is very common for your insulin resistance to drop as very high blood sugars cause a secondary insulin resistance which vanishes when the normal range is achieved. Monitor your readings closely to see if they remain normal and contact your doctor (or whoever set your dosage) to report this change.

C said...

Jenny, Thank you for your reply, I do not know of Diabetes Forums, can you suggest a popular one?

Speaking of Onglyza, you may recall I had previously posted my Endocrinologist prescribed this and after reading about it told him I wasn't going to take it. Recently I asked him how I should safely dispose of the 3 months supply and he said I could bring them in and they could give them as free samples. Knowing what I know now I would not feel good about these being given to others so I will have to find another way to dispose of them.

Jeffry Calhoun said...

Have followed very strict low carb diet for years, with exercise, and 500mg x2 metformin, resulting in 130-170 blood sugar. 2 years ago, this changed & I have been struggling ever since, and during the past 2 months it has got worse- 300+ levels, with 3x 500 mg metformin (the max I can tolerate, with some diarrhea) and Actos (more diarrhea). Then I tried glipizide and Januvia, neither of which is tolerated (extreme diarrhea). I discontinued temporarily the Actos & Metformin in order to judge how bad the others give me diarrhea (very bad). Just switched to this Onglyza, and it alone gives tolerable diarrhea. Hope to add slowly Actos and Metformin.

The advice given on the referred to site on How to Lower Your Blood Sugar- been there, did that, and that no longer is sufficient. Don't know yet if the Onglyza or this combo will lower it enough.

I'm tired of so many places saying that you can get rid of diabetes. Not if you REALLY have it. The only thing other than insulin that I have not yet tried is suggested by Dr. Julian Whittaker- eliminating breakfast in a desperate attempt to lose weight (thus increasing insulin sensitivity). I'm worried that the resultant ketosis will bugger things up when Onglyza is taken.

I'm serious- only 10-15 g of non-fiber carbs per day; 30-40 g of pure fiber daily, limited food; exercising 1 mile 3x/day, and strictly following orders. All of this has made me feel very, very sick. Bathroom every 20 minutes with VIOLENT diarrhea for 6 hours, up till now. Eliminate all drugs, that goes away, but blood sugar goes to 300-600.

Jenny said...

Jeffrey,

It sound like you are low on insulin, in which case no diet will control your blood sugars. Fortunately, fast acting insulin at meals will control them, very nicely. So you probably need to get to an endocrinologist who will give you an effective insulin regimen.

Read up about how to combine insulin and LC in the book, Dr. Bernstein's Diabetes Solution by Richard K. Bernstein, M.D. and keep at your doctor(s) until you get the right treatment.

I also wonder, given your diarrhea issue, whether you might have an autoimmune problem in your gut. Your diarrhea isn't a typical LC or diabetic symptom. And if you have an autoimmune attack going on in your gut, it might also be causing an attack on your beta cells. All the more reason to get to an endocrinologist and get started on insulin.

Whitaker is very ignorant about diabetes and has no training in endocrinology. People with diabetes who skip breakfast will see their blood sugars rise, which makes them MORE insulin resistant, not less. You should eat as soon as you awake because that typically will knock down the "dawn effect" that most people with diabetes experience.

Insulin doesn't hurt and used properly it can allow you to eat about 100 g a day of carb and get excellent blood sugars. There is no reason to take potentially dangerous pills that don't give control when this long-understood alternative is available.

Have some pizza said...

I recently took myself off Onglyza (after taking free samples for about 2 months) because I can't afford it but now, being off it for 5 days, I'm happy I did because there is no difference in my blood sugar levels. I'm also taking Metformin, 500 mgs, 2 tabs a day. Initially, when I diagnosed myself (haha) with diabetes, my sugar was a whopping 627 (without medication). It is now in the 90 to 110 range. With or without the Onglyza, this range stays the same. After meals, it goes up to about 130. I have no idea why my doctor put me on both Onglyza and Metformin but at $326 a month, there is no way I'm taking Onglyza. And now after reading your posts, Jenny, I'm VERY glad I'm not taking it. Plus, my hair is falling out!! I know someone else mentioned this, too. These drug companies and the FDA are full of crap--their main objective is to make as much money as possible, without any regard for your health--keep that in mind. Anyway, now without Onglyza, I'm sure my lovely, thick hair will return and my blood sugar will stay low on just Metformin.

Jenny said...

Glad to hear you are doing so well.

Doctors put patients on these expensive new drugs because drug companies spend billions marketing their newest most profitable drugs to them and their marketing is very effective. They have told many family doctors that Onglyza (and Januvia) can regrow beta cells in people with diabetes, suggesting it could lead to a long term cure. This is a lie, but one drug salespeople have used successfully with every new diabetes drug for the last 15 years. When the claim is disproved by research it never gets any press, but the small, cherry picked studies the drug companies use to suggest that effect, early on, are heavily promoted.

Dahlia`s MaMa said...

My encrinologist put me on Onglyza yesterday as he suspects metformin is causing my reading of stage 3 kidney damage(37).I am considering using insulin IE:Flexpen.Is it hard to control sugars with it? I usually have a fsting morning of 125-128 when using metformin.Im scared.I come from a high risk cancer family.Both my parents plus most of my uncles and aunts died of cancer.I have cousins that have had odd cancers.Im 60 yrs old.I outlived a lot of them.I dont know what to do.

Jenny said...

Dahlia,

The drug companies are putting a lot of money and effort into raising doubt about the findings connecting these drugs with cancer, and your endocrinologist is probably too busy to read the actual studies and may trust what he reads in newsletters dependent on drug company advertising.

If it were me, and I had that kind of family history of cancer, I would go with fasting insulin (Levemir) rather than Onglyza.

However, with those fasting numbers, which are not extremely high for someone with diabetes, you might want to consult a kidney specialist, to find out if something else is going on with your kidneys. Metformin is not known for causing kidney failure, though it may not be safe to take when kidneys aren't working properly, because it might allow lactic acid to build up in the blood. Endocrinologists, in my personal experience, can have a mediocre grasp of other health problems outside of their specialty.

Finally, have you tried lowering your blood sugar using the technique described here: http://bloodsugar101.com/how.php . If you are still eating a high carbohydrate diet you might see dramatic changes in your fasting sugar and your kidney health. The idea that low carb diets damage kidneys has been disposed of by better research, and I know a few people who have improved their kidney health by normalizing their blood sugar by cutting carbs. You can read more about kidney damage and blood sugar (and other issues) here: http://www.phlaunt.com/diabetes/16351841.php

SophieB said...

I was diagnosed 8 years ago, and was put on Metformin right away. It worked and by eating well and taking care of myself I was able to get my levels under control. I got to a point where I was able to go drug free for about 2 years, until I got pregnant with my first child. Then I was on insulin (NovoRapid, and another one) for the duration of my pregnancy. After the birth, I went back on Metformin and was able to keep my levels safe.

Then I got pregnant with my second child... back on insulin. No problems. I loved being able to control my sugars with insulin. After this birth, however, I began suffering from different types of anemia, and my health was gradually getting worse (eg. frequent lung infections, sudden allergies, etc...).

At one point they tried to put me on Januvia. I very quickly reacted to it with swelling in my feet and legs along with headache. So we stopped it, and my sugars we okay.

This year, I had a lot of stress in my life and it negatively affected my diabetes. Sugars started soaring. My hbA1c was up to 12.9, with post meal-time readings of an average of 15mmoL.

I started Onglyza in the mid-late spring of this year. It lowered my levels slightly, but not enough. I also began to have dizzy spells and episodes of hypertension. These symptoms have progressed to the point where my blood pressure is frequently elevated. I also have increasing debilitating headaches and sinus pressure.

My family doctor started me on Lantus in September and that has made the difference we were looking for in my blood-glucose levels. Yesterday, he decided to take me off of the Onglyza. He's worried that I'm showing signs of pancreatitis.

I'm wondering; Does anybody knows how long it should take for the Onglyza to be out of my system?

Jenny said...

SophieB,

There is no research to answer your question, as the drug companies downplay all the serious side effects of their drugs.

From my own experience with related drugs, I'd say it is likely you will see your blood pressure drop pretty fast and the headaches go away pretty fast. Pancreatitis from these drugs appears to result from the growth of abnormal beta cell clusters in the pancreas. How fast this happens is unknown, again because the drug companies have put a lot of money into assuring influential doctors that their drugs don't cause pancreatitis, in spite of the evidence.

However, your symptoms aren't those of pancreatitis and you only took the drug for a short while, so you probably will be okay.

That said, with blood sugars as high as you were experiencing, you probably could use a shot of fast acting insulin at meal times to cover the carbs in your food. You might need to see an endocrinologist to get that prescription. It would be a good idea. A doctor who prescribes Onglyza for the kinds of blood sugars you suddenly experienced may not have a very good grasp of diabetes treatment and may be getting his "diabetes education" from drug company reps.

So if you can see an endocrinologist, you probably should do so!

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