Introduction


#1

First, I should note that as of July 28, 2007, I am not personally a Symlin user, so be forewarned that I cannot share any personal information on this treatment, rather, I am just the person who started this forum as a place where people can share information on this treatment and their experience, advice, warnings and other info. related to treatment with Symlin.



The San Diego Union-Tribune, the hometown paper for the city in which Amylin Pharmaceuticals is based, had perhaps one of the more comprehensive stories on Symlin’s approval from the FDA, which can be viewed here.


For background information, I have collected the following list of resources:

Symlin (company operated website)

Pretty self-explanatory, this site is operated by the manufacturer(s) of Symlin, although patients should consider the information contained on this website with caution and understanding that truly objective information may be limited at this particular site. For somewhat more balanced information, please refer to the other links here.

http://www.symlin.com/

Amylin Pharmaceuticals

Amylin Pharmaceuticals, Inc. is a San Diego-based company founded in 1987 responsible for the development and commercialization of Symlin. Although Amylin Pharmaceuticals was the developer of Symlin, the company has partnered with pharmaceutical company Eli Lilly and Company to actually commercialize Symlin. Lilly brings manufacturing and marketing expertise to the partnership, although both companies share profits from the product itself.

http://www.amylin.com/

Impact of Pramlintide on Glucose Fluctuations & Postprandial Glucose, Glucagon & Triglyceride Excursions Among Patients With Type 1 Diabetes Mellitus

In this study, the addition of pramlintide to insulin therapy reduced excessive 24-hour glucose fluctuations as well as postprandial glucose, glucagon, and triglyceride excursions in patients with type 1 diabetes intensively treated with insulin pumps. *** Note: This study was funded, in part, by the manufacturer. ***

http://care.diabetesjournals.org/cgi/content/full/26/1/1

Amylin Replacement With Pramlintide in Types 1 & 2 Diabetes: A Physiological Approach to Overcome Barriers With Insulin Therapy

A scientific overview of new type 1 diabetes treatment Symlin from the medical journal Clinical Diabetes.Many insulin-treated diabetic patients still fail to achieve optimal glycemic control and continue to experience problems with hypoglycemia, weight gain, and postprandial hyperglycemia. Adjunctive therapy with pramlintide, a synthetic analog of the human amylin hormone, facilitates a significant improvement of postprandial and overall glycemic control in patients with either type 1 or type 2 diabetes without an increased risk of hypoglycemia or weight gain. *** Note: Co-Authors Christian Weyer, MD, is medical director, and David G. Maggs, MD, MRCP, is senior medical director at Amylin Pharmaceuticals, Inc. ***

http://clinical.diabetesjournals.org/cgi/reprint/20/3/137

Effect of Adjunctive Pramlintide Treatment on Treatment Satisfaction in Patients With Type 1 Diabetes

The following article shows that patients with type 1 diabetes had greater satisfaction with treatment after receiving Symlin compared with placebo, according to the results of a study reported in the February 2007 issue of the medical journal Diabetes Care. *** Note: This study was funded, in part, by the manufacturer. ***

http://care.diabetesjournals.org/cgi/content/full/30/2/210

FDA Center for Drug Evaluation and Research Endocronologic and Metabolic Drugs Advisory Committee

Meeting Summary Minutes for NDA 21-332, Symlin (pramlintide acetate) Amylin Pharmaceuticals, Inc., July 26, 2001.

http://www.fda.gov/OHRMS/DOCKETS/ac/01/minutes/3761m1.htm

FDA Presentation for Symlin (pramlintide acetate)

Presentation made to the FDA seeking approval of this new treatment for type 1 diabetes by the manufacturer, Amylin Pharmaceuticals, Inc.

http://www.fda.gov/ohrms/dockets/ac/01/slides/3761s1_01_amylin.ppt

FDA Approval Letter for Symlin (pramlintide acetate)

Letter from the FDA regarding Symlin's approval by the drug-regulating agency.

http://www.fda.gov/cder/foi/appletter/2005/021332ltr.pdf


#2

Like Scott, I am no longer a user of SYMLIN. But I do reserve a bottle of it in my fridge as a memento. I stopped using GM insulin in May 2007 and switched to natural animal-derived insulin. I quickly found that I no longer felt the need to quell insatiable hunger after insulin.

When I did use SYMLIN, however, I noted a crawling tolerance of it. When 5 units would work the first week, I would need 6, 7 and sometimes even 10 units in the following weeks. Amylin isn’t kidding about that 3 hour duration, either.

Symlin (the synthetic form of amylin) is an adjunct therapy for diabetes management. But if genetically modified human insulin was made properly in the first place – we never would’ve needed something like this. Amylin is insulin’s partner hormone that suppresses glucagon. It is cosecreted with insulin – but you cannot combine insulin and SYMLIN. It’s kind of self explanatory why they took the hormone stimulating piece out of genetically modified human insulin. It barely penetrates the brain! Who needs that big blog of fat anyway? Big Pharma’s got it under control.


#3

To be completely fair, I should note that Symlin is the first version of the human hormone amylin which is completely absent in patients with type 1 diabetes, so I do believe it has a justifiable place in treatment. We should also try to be adding another hormone, known as somatostatin, which is made not by the beta cells, but the delta cells which are found in the Islets of Langerhans, as well as C-Peptide, which is not a hormone, but a residual peptide that is now known to have beneficial effects on patient physiology. Patients with type 1 diabetes are missing all of these hormones and peptides. The real challenge in replacing hormones like insulin as well as amylin and somatostatin is that none are replaced in a physiological manner and can therefore pose special challenges, but these are more of a debate on what appropriate treatment should be.

My real objective is for this to serve as an information resource for patients seeking information about this treatment, so thanks for your input, and I hope you will be an active participant in this group!


#4

Scott,

I never heard about Symlin until you started this forum. So thank you for starting it. I will be sure to read some of the links you provide to educate myself.


#5

Thanks for starting this Scott. I have been seriously thinking about starting on Symlin in the fall after hearing others have success with it so it is great to have one place where there is a collection of information on it from various places.


#6

Thanks for joining us Khurt, I hope we can serve as a forum for sharing information and personal experience with this new, adjunctive treatment. Nikki, like you, I have been asking my endocrinologist about Symlin, but so far, he doesn’t have any patients using it. I looked around for user groups online, and was disappointed not to find very many on most of the major public forums, including the American Diabetes Association, dLife, JDRF, Yahoo! Groups, so I decided we could assemble the best group here. I hope you both will ask a lot of questions (we have a few actual users already, and I hope to add more in the near future). Stay tuned for more to come …


#7

I am also a former - maybe future - user of Symlin. The vials are still in my fridge and I am sure I can get a new sample from my endo once they expire.

Here was my problem with it:
I sampled it at the same time that I sampled the DexCom, so I knew exactly (well, close to) what was going on with my numbers while I was taking it. I tried taking it according to the manufacturer and endo’s directions. It did not work.
I would have great post-prandial numbers (with 10 units Symlin and slightly reduced bolus), followed by an incredible spike an hour and a half later.
The only way I could get it to produce the results advertised was to take 10 units of Symlin as directed with meals. I would only bolus if a correction was needed. Then, about an hour and a half later I would test my blood sugar and bolus based on that and the amount of carbs previously eaten.
It was a lot of math and a lot of remembering. It did not reduce my insulin use or aid in my weight loss goals.
I guess I decided it was not worth it for me at this time.


#8

Hmmmm … that’s a first. I’ve heard decidedly mixed reviews of Symlin (some who love it, others who found it to be the most annoying pharmaceutical they ever tried), and the complaints vary. Some people noted that the titration period (the time when you are going from the initial starting dose up to the fully recommended dosage) differs, and that people should disregard the time it takes to get to the full dosage (mainly to limit the side effect of nausea) and do so at their own schedule (remember, the packaging are recommendations only).

Not knowing much about you, I wonder if you’ve been tested for either celiac disease or gastroparesis? The reason I ask is because theoretically, Symlin slows down the movement of fluid and/or food out of the stomach and into the intestine (and thereby reducing post-meal the blood glucose levels) and also induces satiety (or feeling of fullness), which is what supposedly accounts for Symlin’s effect on weight management. Anyway, if you are then slowing the movement of food from the intestine which already moves at an unpredictable speed anyway due to a condition like celiac or gastroparesis, then it would seem to me that could explain the spike you had an hour or more later. Just a thought, but its best to ask a doctor, perhaps a specialist in a field like gastroentrology rather than an endocrinologist.

We do know that timing the injection of Symlin has required some study. According to Dr. Steven Edelman, assistant professor of medicine at the University of California San Diego School of Medicine, “We now know that Symlin is best given right at the beginning of the meal or a few minutes before. And, for most folks, between 15 and 30 minutes after injecting, we notice that they start pushing away their plate and they eat less [about 25% fewer calories] … It has such a dramatic effect on their satiety that they eat less than they were going to eat and they might end up in a hypoglycemic reaction. So, for that reason, we have them take their fast-acting insulin near the end of the meal once they have seen how much they have eaten.” I don’t know if that is an issue for you, but it may be worth considering. Also, unlike insulin, which has different peak effects, Symlin is specifically designed to lower glucose levels after eating. That’s why it is taken only before meals with at least 30 carbs or 250 calories.

Anyway, these are exactly the type of issues I hope to hear about so that we can get them out and hopefully work to resolve them for everyone (or prevent someone else from having a negative experience someone else went through). Thanks again for your feedback!!


#9

Sara - Maybe this is a silly question but did your doctor have you using a combo bolus (or square bolus I believe as some refer to it) when you used it? My understanding is that when you use Symlin you have to take a small portion of your insulin when you eat and the rest over the course of a few hours. I’m guessing that if you weren’t told to do that it could account for your spike after about an hour and a half.


#10

First of all, thank you Scott for starting this group. I was really hoping to connect with some more people about Symlin and this seems to have gotten people’s attention.

I have been using Symlin since last August, so I am almost up to a year now. I primarily started it to control post prandial excursions, but I have lost weight on it. I am not sure how much weight I can directly attribute to Symlin, as I was already losing weight due to stepping up my exercise routine, but it definitely sped up when I started Symlin. I don’t think it really reduced what I ate at meal times, but made what I ate stick with me for longer so I was less inclined to want a snack a few hours later.

I started out with the recommended titration and got up to 10 units. I noticed a lot of lows at 1 hr after eating, followed by a rebound at two hours. At the time, I was on MDI with Novolog and while reducing my insulin helped some to avoid the lows, it made the rebound all the worse. As a result, I started taking most of my mealtime insulin as Regular insulin to sort of get the extended bolus effect. But I still had some lows, particularly in the morning so I reduced the insulin some more, played around with timing both the insulin and the Symlin, but the two hour numbers got worse and I was still have bad lows in the morning a couple of days a week. So I halved the Symlin and have been much happier since.

Three months ago I started on the pump, and it has been like I get to learn how to dose all over again. You have more control over your mealtime boluses, but that means more variables to play with and get right. Dinner I have gotten down pretty well. I use a combo bolus with 30% up front and the rest over 90 minutes. I sometimes get a little of the pattern I noticed before: drop for the first hour, then rebound by the second, but it is a slight effect and I am really quite pleased with the tight range my numbers stay in following supper. (I should mention that I don’t take Symlin at lunch because I don’t have a peaking problem then.)

Mornings are the bane of my existence. I am pretty good at avoiding the lows now in the morning, so I stay practically even for the first hour. Then, like Sara, I notice a huge surge and peak at somewhere around 2-2.5 hours. Seriously, it goes up 100-200 mg/dL in an hour. The best solution I have is to take about 20% of my insulin when I eat, then the rest an hour later after I get out of the shower. Any combo or extended bolus taken at meal time just doesn’t give me the big peak of insulin action I need at two hours. Actually, this week has been quite lovely BG wise in the morning.

Anyway, that is my long Symlin story. Hopefully it will be of use to someone.


#11

Visiting a gastroentrologist - that is 6+ months of my life and countless dollars that I will never get back. Ultrasounds, CAT scans, multiple blood draws… Towards the end the appointments were: “We still have no idea what is going on, make another appointment for next month to check back in.” No diagnosis. There is something ‘off’ with my digestion, but they cannot figure out what.
I am sure it probably contributed to my dislike of Symlin.
I did take it as designated (whenever possible) at least 15 minutes, but usually more like 20-30, before eating. And I only took it when I knew I was going to have at least 30 carbs. I followed all the directions.
It was not the fault of the Symlin, in my opinion, it was the fault of an unpredictable digestive and endocrine system. :stuck_out_tongue: