An Open Letter to Novo Nordisk

I promptly called my doctor and said that even though I knew that Victoza was not approved for type 1 patients, I wanted to try it. This would be “off-label use,” as the jargon goes.

I want to stress that if you ever consider taking anything not approved for a specific use, you have to talk to your doctor. Your doctor can approve it, but only with careful thought and with a full discussion about the possible benefits and risks.

I was fortunate. My doctor knew the safety background of Victoza very well, and she knew that I had had a hard year with my diabetes. I was thrilled that she approved my use of this new drug. 

Thrilled, but also cautious, I delayed starting Victoza for some time because I had heard that this type of medicine causes nausea. I also had major work commitments, and then we were going on vacation.

When I finally started in August, I was a little nervous.

There are three approved doses with Victoza: 0.6, 1.2, and 1.8 milligrams (mg). I was motivated to lower my A1c, to reduce the variability in my blood glucose, to feel better, and to lose weight. But I never dreamt that all those things would actually happen – and in my case, so fast.

At any rate, I took my first Victoza dose of 0.6 mg. I felt nothing. No change in my blood glucose.

Though the instructions said to take 0.6 mg for one week, I ignored that and the next day I took 1.2 mg. What can I say? I’m an impatient patient. Well, I threw up the entire night!

I guess I’m stubborn as well, because when I looked at the pen the next day, I noticed I could take 0.6 mg again or that I could take a tiny bit more – there were five clicks to the pen between 0.6 mg and 1.2 mg. Presumably, the first click was 0.7 mg, the following 0.8 mg, etc. My doctor had told me to take 0.6 mg for a week, so I did that for several days and then feeling no nausea, I took 0.7 mg – although this contradicted the “official” titration schedule (titration means how you move up from a low dose to a higher dose), I couldn't help but notice on the pen that it was possible to make smaller “increases” than officially recommended. And, I assumed (correctly) that moving up more slowly prompted less nausea. I felt a little bit of nausea that first week but nothing that was a big deal.

By the time I got to a 0.9 mg dose, my glucose numbers were evening out. I was actually waking up with hypoglycemia and kept reducing my basal rate. By the second week, Gary Scheiner, my across-the-country Skype educator, asked me if I was taking less insulin. I said I didn’t know, and he said, “Um, one way to find out. Check your total daily dose on your pump.”

I did and I gasped! Before starting Victoza, I had been routinely taking about 40 units a day, and sometimes as much as 45 units a day. But the pump told me that for the previous two weeks, I had taken between 25 and 30 units! Now, after a couple of months, my insulin intake is typically between 20 and 25 units, only higher if I have a really big, high-carb dinner.

Someone asked me how I use Symlin in my new diabetes regimen that includes a daily shot of Victoza. While initially I stopped using Symlin for a little while, I’m now using it again, with insulin and Victoza – not before every meal, but definitely before all my high-carb meals. My sense is that as a patient with diabetes, I am probably missing multiple important hormones. Symlin works very well for me in lowering my post-meal blood glucose levels and when I’m eating pizza or a sandwich or fettucini, I still take Symlin to reduce these numbers – and it does. I am eager to eventually try a insulin/Symlin combo, since I have heard from so many people that Symlin works best in a pump – here’s hoping that will be developed soon. (I tried Symlin in an extra pump myself and loved it and only quit because my insurance didn’t reimburse the extra pods – I’d rather wear one pump and have the combined insulin/Symlin to take, if this could be created in a formulation that worked for many people.)

I am worried about waking up “high” – and of late that hasn’t been a problem. My numbers in the morning are often low (my CGM wakes me), or they are around 70-80 mg/dl – this is amazing.

My CGM tracings have also improved markedly. They are not perfectly flat, but they are much flatter than they were and now they zig-zag more within the zone, not outside it! If I eat Chinese food or pizza, my blood sugar numbers will still go sky high (we haven’t cured diabetes, after all), but it’s far more likely I pick up my CGM these days and see 80, 90, 119 mg/dl. What is amazing is how many fewer highs I have – and this has made me realize how many highs I was overtreating and then going far too low, overtreating, etc. The numbers look good – the time spent high (over 180) has gone down 70%, and my time in zone has increased 20 percentage points to over 70% (on my CGM, my time in zone is between 80 and 180 mg/dl). And, I’ve lost nearly ten pounds! I did get my A1c checked when I began Victoza, and it was 7.1% – not as low as I’d like, but I really feel Victoza has had an effect and I feel certain (and will update this column!) the next score will be lower. I’ll have my A1c checked again at the three-month mark, but I can already tell from my CGM that because I’m “in zone” so much more that I’m doing much better. Another piece of good news is that my hypoglycemia in the day has been reduced (since I'm not chasing so many highs down); I also think the average hypoglycemia rates will drop in the early morning hours once we refine the best basal rates (we're still dropping them!).

The biggest bonus may be something that no one can quantify: I feel better and am somehow less tired. My wonderful husband said to me a couple of weeks after going on this GLP-1, “You’re so much nicer on Victoza!” Wow. What more could anyone want.

Oh. One other very important thing. Victoza is expensive, so I'm lucky that my insurance did actually approve it. (I got my first two pens as samples from my doctor.) My co-pay isn't insignificant at $50, but this would be over $300/month without insurance, so I'm very happy about the cost, whether or not it is a mistake… (Victoza isn't approved for type 1 so I'm surprised that my insurance did approve it, since insurance typically does not cover therapies for unapproved uses - I'm hoping this lasts but not necessarily expecting it to.)

I’m not suggesting that Victoza is a miracle drug or a diabetic elixir. It’s not, but it is working for me in new ways and complementing the insulin. Clearly, my pancreas doesn’t make insulin any more, so the drug is not working in exactly the same way it does for people with type 2 diabetes. But GLP-1s also affect appetite (you don’t get so hungry) and satiety (you don’t eat such large portions) and they also reduce the amount of sugar that the liver releases into the blood. My guess is that the combination of these things leads to weight loss and better control after meals. We don’t really know for sure because there is relatively little work has been done on GLP-1 and type 1 diabetes.

The main point – and a big reason I’m writing this column – is that I’m disappointed that I have to take Victoza “off label,” which connotes something improper. I understand that many type 1 patients won’t try Victoza for just that reason. And I wouldn’t ever encourage anyone to take a drug off label! But, the only way to remove that barrier is for Novo Nordisk to begin meaningful trials with type 1 patients – and I wish this had been done long ago.  Large-scale trials aren’t cheap, but they’re necessary to gain the approval of products that can achieve real breakthroughs. Insulin likely isn't the only thing type 1 patients are missing - here's to a study that can find out more about gut hormones in type 1 diabetes.

I realize, in my case with Victoza, that I am a sample of only one, but in that one, Victoza not only improved my glucose control but also bolstered my faith in the continued progress of diabetic therapies. All type 1 patients should have that opportunity. I urge Novo Nordisk to make the commitment, make the investment, and make it happen.

And, thank you to the researchers and scientists who developed this new class. You've made me feel so much better, all of you. Thank you, thank you.

* * *

Here is Novo Nordisk’s response to this column, which was originally published in diaTribe #26. We thank them and very much hope to see Victoza studied in individuals with type 1 diabetes soon, either through company-sponsored or investigator-initiated trials. For now, I feel very lucky to be able to take Victoza and am happy to personally take on the additional risk. This column should not be perceived as any recommendation for any individuals with type 1 diabetes to take Victoza as an adjunct to insulin, but we do hope any companies studying GLP-1 will examine its use this patient population soon.

Novo Nordisk’s Response

Dear Kelly,

We read the diaTribe article describing your recent experience using Victoza® as an adjunct to insulin to treat your type 1 diabetes.  We are happy to hear that Victoza® has lowered your mean glucose levels and also has resulted in a decrease in the frequency of both high and low glucose levels.

Our development program established a strong foundation for the use of Victoza® as monotherapy or in combination with one or two oral agents in type 2 diabetes.  As you pointed out, Victoza has not yet been studied in or approved for the treatment of type 1 diabetes, and it is not a substitute for insulin. However, your personal experience provides one of many reasons why Novo Nordisk is currently considering exploring the use of Victoza for type 1 diabetes in well-designed, controlled, randomized clinical trials.  While we can not guarantee the time course or the outcome, we are carefully evaluating the possibilities for launching such a program.

Thank you for making us aware of your experience and for sharing so many insights about living with diabetes.

Best regards,
Alan C. Moses, MD, FACP
Global Chief Medical Officer
Novo Nordisk A/S

Mads Krosgard Thomsen
Chief Scientific Officer
Novo Nordisk A/S