Byetta: Miracle drug for perfect BG control for recently diagnosed T1’s?

Treatment Oral Medications and non-insulin injectables
1

I’m a T1 LADA diagnosed about a year ago and have found tremendous BG control using Byetta at Lunch and Dinner (mid 80’s mg/dL), but discontinued using it in March due to a concerning study released by the UCLA Medical School on potential side effects.

Here’s my story and I’d welcome your thoughts, comments and advice in continuing its use, as well as your experience with Byetta if you’ve used it.

I was diagnosed in May 2012 with an A1c of 8.8% and fasting glucose of 236 mg/dL. Tested positive for both GAD and Islet antibodies. C-Peptide at diagnosis was 1.2 and plummeted to 0.2 within about 4 months. For perspective: My A1c was 5.4% at my regular annual physical exam only 6 months before being diagnosed as a diabetic.

I got frustrated with my local endo for reasons not worth elaborating for this discussion, and became a patient of Dr. Bernstein in Sept. By this point I was already following a low carb diet as recommended by Dr. Bernstein (30g/day) and Jenny Ruhl and covering my basal Insulin needs with 18 units of Levemir (9u – morning, 9u – bedtime), breakfast with 1 unit of Humulin R, lunch and dinner with 2 units and 2 units of Novolog, respectively. Fasting and 2hr post meal BG was consistently between 75-95 mg/dL.

One thing I began to struggle with was post lunch and post dinner cravings. This is not uncommon for T1’s, as one of the byproducts of endogenous insulin production is amylin, which creates the sensation of satiety, and I was hardly producing any of my own insulin anymore.

As those of you who have read Dr. Bernstein’s books know, he’s been very successful in helping his T1 patients curb these cravings with “off label” use of Victoza, Byetta and other incretin mimetics. Victoza and Byetta were developed for T2’s and assist in BG control, and were not intended for T1’s at all. However, because these drugs cause delayed stomach emptying, they also create a sensation of post-meal satiety, and hence can be effective in treating cravings in both T1 and T2 patients.

I started with Victoza and found it extremely effective in ending my cravings – almost immediately. However, it also shot up my total cholesterol from 170 to 240 in four weeks, driven entirely by a rise in LDL or “bad” cholesterol. After going through the accompanying documentation I saw that there was a small group of people in the Victoza trials that had experienced the same side effect. I stopped using it and my cholesterol dropped back to 170.

I then switched to Byetta. It too proved extremely effective in eliminating cravings, without impacting my cholesterol at all. The downside to the dosing is that it is not adjustable like Victoza. Byetta comes in two fixed dosage pen types: 5mcg and 10mcg.

I used the 10mcg dose pen along with 2 units of Novolog at lunch and again at dinner for about 3 months. BG control remained good and cravings were gone. Then, at the end of December an interesting and terrifying thing happened soon after dinner: my BG plummeted to 40 mg/dL., and I had made no changes to my insulin or diet regimen.

I then began to wonder if I was beginning to realize some BG control benefit from the Byetta, so I experimented with not injecting any insulin to cover meals and only injecting the Byetta. My post meal numbers were landing in the 80’s. I was amazed. Originally I was only using this to cover cravings, but now it too was providing me with some sort of returning endogenous insulin production. Not only did it give me perfect post-meal numbers, it also seemed to revive my first phase insulin response. My BG stayed flat during and after the whole meal. By this time I was using a continuous glucose monitor to validate this. There is plenty of anecdotal information suggesting these types of drugs can revive beta cells, and it seems this was the case with me.

This was nothing short of a miracle in my opinion and I began to experiment further. I found that it was only good in covering two of my meals a day. I tried injecting it before breakfast, lunch and dinner and found it covered breakfast and lunch, but by dinner the efficacy was gone. Maybe my beta cells were exhausted by this stage? I don’t know. Since my breakfasts were the easiest to cover with insulin, I used the Byetta for lunch and Dinner.

Note that I was still taking my daily Levemir dose, but my needs were starting to rise. In Jan I was up to 20 units/day.

I maintained my low carb diet but couldn’t help experimenting with some “off-plan” foods. For example, I tried a pre-packaged, white bread sandwich offered on a flight that had 70g of carbs listed on the label; zero rise in BG and I remained flat at 85 mg/dL. I had the same result with a cup of vanilla ice cream. Pizza was different: I remained at 80 mg/dL for almost two hours and then shot up to 200 mg/dL, requiring a Novolog correction. Again, these were just experiments and did not become a regular part of my diet.

Then in Feb I started going low after meals with the 10mcg Byetta dose, which suggested to me that my mealtime endogenous insulin production was improving even further. I was then able to cover lunch and dinner with only a 5mcg dose on my low-carb diet. I was now covering breakfast with 2 units of Novolog.

In my consultations with Dr. Bernstein I hypothesized that what was occurring could be the revitalization of my beta cells to the extent that the Byetta was lighting them up just long enough to cover my meals but not so long as to provoke an increased auto-immune response because my C-Peptide numbers held steady at 0.2. He felt that there was merit to this idea, but without any studies supporting this it was difficult to say it was conclusive. All I knew was that this drug worked, and it worked brilliantly. Why? Neither one of us was exactly sure.

By the end of March my Levemir requirements had risen further. I was up to 34 units/day and I was covering my breakfast with 3 units of Novolog. Lunch and dinner were covered with 5mcg of Byetta, respectively. C-Peptide was still holding steady at 0.2.

This was also when Jenny Ruhl posted the alarming results of a just released UCLA study on the side effects of Januvia and Byetta: http://phlauntdiabetesupdates.blogspot.com/2013/03/byetta-victoza-bydureon-appear-to-cause.html

After reading Jenny’s summary I bought and downloaded the actual study and sent it to Dr. Bernstein for his opinion. The study concluded that Januvia and Byetta did indeed spur the growth of beta cells, but they were abnormal. Jenny summarized “The Fatal Flaw with These Drugs: They Cause Abnormal Cell Growth and Pre-cancerous Tumors in the Pancreas.” The study was performed by dissecting the pancreases of participants who had been using Januvia or Byetta for at least a year and had died from non-diabetic related consequences. Bear in mind, the sample size was small: 7 people used Januvia, 1 person used Byetta, 14 non-diabetics were used as a control group. All of the Januvia and Byetta users showed abnormal growth.

I discussed what I should do with Dr. Bernstein. He stressed that while the results are concerning, the sample size was so small it is difficult to argue that this is conclusive. Since there was only one participant who was using Byetta, it is a statistically difficult case to make.

Regardless, I decided to err on the side of caution and discontinue using Byetta regularly. I use it occasionally when I’m at a business dinner in places like Asia where I cannot accurately gauge the protein/carb contents of many of the dishes, and sure enough, it consistently lands me in the mid 80’s. My cravings between lunch and dinner and after dinner have subsequently increased, but nowhere near the levels before I began this journey with Victoza and Byetta. Previously the cravings were all-consuming, now they’re moderately annoying.

I’ve been covering all my meals with Novolog since the beginning of April and some interesting changes have occurred. My 24hr dose of Levemir is still 34 units, but I’ve had to skew the split in favor of my nighttime dose in order to constantly land between the 80’s to 90’s in the morning. Whereas, previously I was splitting my dose exactly in two between my morning and evening injection, I’m now injecting 23 units at bedtime and 11 units in the morning. My mealtime Novolog doses are now 3, 6, and 6 units for breakfast, lunch and dinner, respectively. My diet and exercise has not changed at all over this time. Net: my basal requirements have basically doubled and my mealtime requirements have tripled since September last year. However, my C-Peptide remains at 0.2.

This experience leaves me with some key questions:

  • Was my increase in insulin requirements hastened by my Byetta usage? Did I burn my beta cells out or was this just the natural progression of the autoimmune destruction? The consistent C-Peptide value seems to suggest neither, but why do I need more insulin? Remember, diet and exercise have remained consistent over this whole period.
  • Did the Byetta foster growth of “abnormal” beta cells as per the UCLA study? Maybe, since I was getting excellent mealtime coverage but my basal needs increased over time. The only way to know for sure is through an autopsy, and I still plan on hanging around for a while. ☺
  • Why have I needed to move my basal dosing from a 50:50 night/morning split to a 70:30 split? Dawn phenomenon is the simple answer, but my CGM was showing rises early, middle and the end of my sleep cycle with no clear pattern.
  • Do I need to worry about pancreatic cancer? Although difficult to diagnose early, one of the early symptoms is an increase in insulin requirements, which in a non-diabetic would be a red flag, but in a diabetic could be due to any number of reasons.
  • Should I continue using Byetta? The benefits have been nothing short of remarkable for me. Will I enjoy these benefits over the long term if I do? The potential risks, however, are troubling but still far from conclusive.

I welcome your thoughts and advice, especially from those of you that have used Byetta. And thank you for taking the time to read through such a long question!

Christopher

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what oral(s) are you on? who's Rxing you all these orals and injectables, byetta, victoza for type 1 diabetes, is an endo? did you actually see dr. bernstein in person?

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Christopher - Thank you for posting about your experience with Victoza and Byetta. The level of detail in your writing holds my interest throughout your long post.

I don't have anything to add except that when I proposed to my endo off-label use of Victoza, he put me off. He didn't appear to want to go down that road. He was set in his ways in many regards so I'm not sure what his real objection was.

I'll be interested to see what response you'll get here.

Your previous post motivated me to start reading again Berstein's Diabetes Solution. I may join you in the 30 gram/day CHO limit. We'll see.

4

for what i've read about byetta for a newly diagnosed type 1, no way:

"Byetta suppresses glucagon production which would be counter indicative for type 1s. Glucagon blunted as the disease progresses. Typically, we want to keep as much of that response as we can if we are having a low. So between it being useless for insulin secretion, and maybe even harmful with decreasing glucagon in a person who uses insulin."

Additionally, I would highly suggest caution in promoting this type of oral/injectable routine for a type 1 diabetic, (jennie ruhl, reading off dr. bernsteins books). No endo would be prescribing this type of regime for a newly diagnosed type 1, that's just my opionion and I've seen many endos, ha!

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Yes. I Dr. Bernstein is my endo and I see him in person. He prescribes all my medications.

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Valid points Sarah, except the results have been phenomenal in my case. Yes, most endo's would not prescribe this to a T1, but then sadly these are many of the same endos who follow the ADA party line and discourage targeting an A1c below 6.0% and also discourage low-carb eating.

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Thanks Terry:

Yes - I experienced that same rigid thinking with my first endo before finding Bernstein. If there is one thing that he's taught me, it's experiment, test and measure. We all know there is no "one right way" to manage this disease. It's a travesty that there are so many Dr.'s that do, however.

If you are having cravings, I'd encourage you to find a Dr. who can help you test some of these alternative "off label" approaches. What doctors need to understand is that it's all about you, not them.

If you choose to go the low-carb route as per Bernstein, remember that it's the methodology that counts, not the recipes. I've noticed that people are often put off the low carb diet by the foods he mentions, not realizing the choice is much broader than what he writes about. I love the guy - he's a great Dr. but a horrible chef. Trust me, I know. I've had lunch with him many times and there is no way I could feel satisfied eating the foods or the quantities he does.

Good luck!

Christopher

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Right on, Christopher. I eat Bernstein's way but I've never even looked at his recipes. I have more than enough imagination to devise my own menus -- I simply make sure that the amounts of carb and protein I eat fit the plan. Works for me!

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Here are my thoughts:

1. I assume your c-peptide was always drawn fasting. Therefore, that indicates nothing, really, except that your fasting insulin has remained the same. It has very little, if anything, to do with your mealtime responses.

2. For myself, I would consider ANY correctly-obtained evidence that a drug might lead to pancreatic cancer a reason not to use it. That's my personal opinion, specifically for me, but I've also watched two people go through chemotherapy, one through radiation. It isn't pretty and I'd avoid it if I could. The results of those studies seem circumstantial at best, but there are other studies showing negative results with Januvia. I'm not sure about Byetta.

3. My opinion on the reason why your insulin needs decreased it fairly simple.

You still had some insulin production. The slower gastric emptying enabled your islet cells to keep up with the slower glucose output. That being said, if you do that you're putting extra strain on those cells, which is likely to increase the autoimmune attack and leave you with less remaining insulin production.

I'm not on insulin, but your basal needs sound high. My guess is some of that might be coming from inadequate mealtime insulin.

I hope this helps. Good luck!

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My experience with Byetta and Victoza somewhat mirrors yours, although I am diagnosed as a T2. What I found was that both Byetta and Victoza essentially put my diabetes into complete remission. At one point, I ate a burrito estimated at 90g of carbs and had no blood sugar rise at all. Unfortunately, the remission only lasted 2-3 weeks, after which both Byetta and Victoza did nothing at all for me. Dr. B also mentions that he rotates the medications as they appear to wear off after a certain amount of time (3 months I believe he said).

As to the safety, I don't always agree with Jenny Ruhl. In this case, she is not presenting balanced evidence. The sample is too small, the abnormalities could have come from something else and most important, the effect has not been observed. Given that there is probably millions of patient years of experience with Byetta users, if the effect was really there and at all significant you would expect it to have shown up more.

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very helpful post and details of your experience. Thanks for sharing !

Was amylin considered as alternative to byetta, and if so, why was byetta chosen.

I guess I'm lucky to not have cravings. Between meals, I often have a handful of nuts, cheese or avocado, with a small bolus, and then I'm fine till the next meal.

Given your finding, I guess I'd be hesitant to stay with byetta, and consider amylin which claims similar results. (Note - I have never used amylin, and discussed only once with my endo.)

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Hey guitarnut:

Great points.

1. Yes, correct. Fully agree. I think the only real conclusion we can draw is my loss of beta cells has leveled off for now since diagnosis.
2. Totally understand. I've lost loved ones to cancer and it's terrifying, I know.
3. Very interesting hypothesis. Yes, I would agree I still have remaining beta cell function. IM's are also known to "light up" the remaining beta cells. That along with the slowed gastric emptying probably helped. Your theory around risk of burnout sounds plausible. Maybe that's driving the increased basal and mealtime needs.

Yes - my basal needs have increased. I'm not sure if this is due to my "honeymoon" coming to an end or an increase in insulin resistance. The latter seems less plausible since I have lost weight and increased muscle mass during this period, which should result in just the opposite. The basal dosage seems correct, as my BG holds flat between meals and even if I skip meals.

Great insights. Thanks!

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Thanks Brian:

I always follow your posts with great interest. You clearly have a wealth of experience based on everything I've read by you.

Your experience with Byetta and Victoza is interesting. It worked brilliantly for me for almost 6 months, but I wonder if it would ultimately lose it's efficacy as in your case. If so, the benefit might not be worth the risk. Tell me, do you still have some remaining beta cell function?

Yes, the safety is debatable. It's just the consequence of being wrong if it is dangerous that is terrifying.

Thank you for taking the time and your perspectives!

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Hi MegaMinxX

Thank you. In fact, that was one thing I failed to mention. I've just gotten a prescription for Amylin (Symlin) that I will start testing this week.

Dr. Bernstein's order of preference of IM's for off label usage to treat cravings are: Victoza, Byetta and Symlin. This is based on the experience he's had treating his patients and their effectiveness. Although as Brian mentions, he will also rotate them if he finds that one is losing it's effectiveness in managing cravings.

Thank you!

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I am finding this discussion quite fascinating. I don't use any of the three but am considering them seriously. Please keep us up-to-date on your experiences.

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Thanks David:

Absolutely. I should get my prescription tomorrow and I'll start testing it immediately. I'd imagine due to the delayed gastric emptying Symlin causes I will have to change the timings of my injections and/or move exclusively to R in covering my meals, since it is unlikely to trigger an endogenous insulin response like the GLP-1's (Byetta or Victoza).

The "experiment of one" continues! :-)

Christopher

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That's exactly what I do David. I find a ton of good ideas from the Paleo and Atkins community. Just yesterday I experimented with some almond flour pancakes with DaVinci sugar-free blueberry syrup. It was amazing!

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It's time I reread the book, though. It's been a few months, I must have forgotten some bits by now.

19

Why risk the use of oral drugs that may or may not cause cancer when you could maintain that tight control on insulin alone? I was dxed w/ T1 2 yrs ago at the age of 27, and I find it somewhat easy to maintain post prandial bgs below 90 w humalog and the omnipod, as long as i stick to meat and vegetables and avoid all grains and refined foods. I dont even have to follow dr B's restrictions on carbs, I usually eat about 100g/day all from vegetables and nuts.
I would have to think this would be preserving my beta cell function as much as any method could, as long as my bgs are normal at all times(<90 mgdl).

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Hey Shawn:

I agree, but what made this so compelling is that the Byetta seemed to be causing some level of beta cell revitalization or regeneration, making tight control so much easier. BTW - Byetta is an injectable, not oral medication

However, the thought of the Omnipod has also crossed my mind. It's encouraging to hear you're getting the results you are on a similar diet to mine with it.

Thanks!

Christopher