For those who have type 1 diabetes as well as those who help treat it, it goes without saying that managing type 1 diabetes is very complex and can be frustrating. However, every enterprising type 1 that I work with will look at every treatment angle possible to help reduce blood glucose, hypoglycemia, and weight gain. The term “off-label” does not scare away the type 1s I work with and I have learned a great deal about the benefits of GLP-1 agonists in type 1 diabetes.
In the endocrinology department where I work, there are numerous individuals with type 1 diabetes using one of the GLP-1 agonists. I spoke to 12 female patients who have been using them for at least two years. While there are five GLP-1 agonists on the market, these 12 have been using either Byetta (exenatide), Bydureon (exenatide extended release) or Victoza (liraglutide) since they have been on the market for the past two years.
So, why would a prescriber want to use a GLP-1 agonist off-label with type 1 diabetes? What do we already know about its use in type 2 diabetes? Weight loss, reduction in insulin, and improved blood glucose control all have been shown with type 2 diabetes. So, will it have the same effect with type 1? For the patients I work with, the answer is, “we are willing to try!”
When I asked my patients about their experiences, here is what they had to say about using GLP-1 agonists in addition to insulin for their diabetes management:
- This medication has been amazing!
- [For the Bydureon users], I am not a fan of the size of the shot and the welts that are left on my arm/leg, but it is still worth taking.
- The biggest thing it has helped me with, other than diabetes management, was losing weight. [of the 12 type 1 patients I spoke with, the weight loss ranged from 25 to 60 pounds]. It did not magically take the weight away, but the combination of taking less insulin, eating less to correct my lows and to be able to work out/exercise more efficiently did. I could not do that before taking this shot, no matter how hard I worked out.
- By taking this medication, it cut my insulin doses in half. [On average, the typical dose prior to the GLP-1s was between 50 and 80 units; the doses reduced to 20-40 units per day.] And it helped calm down the roller coaster numbers. It helped with the crazy highs, but I still have lows, just not as many of them.
It is important to note that this class of drugs are not always covered by insurance, but the doctor’s office can write a prior authorization to get it covered–if it is not already. There are also the co-pay cards that reduce the cost. Many insurance companies just require that you meet the deductible, then it costs nothing. In Illinois where I live, the cost of a box of 4 pens (any brand) is approximately $2,000.
There is one recent article from the British Journal of Diabetes and Vascular Disease that highlights the benefit of liraglutide in overweight and obese individuals with type 1 diabetes. (1) It included only eight individuals who used liraglutide for 12 months. At 12 months, average weight loss was 8.9 +/- 8.4 kg and insulin reductions were approximately 40 units less than baseline for those in the study. It is well known that Novo Nordisk is attempting to obtain FDA approval of liraglutide for type 1 diabetes, as evidenced of the ongoing clinical trial, The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes (ADJUNCT ONE). While the study is no longer recruiting subjects, the trial is ongoing and the expected trial duration for each subject is 58 weeks, with an estimated end date of June 2015. For more information, please see ClinicalTrials.gov and look for identifier NCT01836523.
Taking a medication that is off-label for type 1 diabetes patients is not something to be taken lightly, and it is certainly a needed conversation between the individual and their prescriber. However, the many patients I work with who have type 1 diabetes have clearly stated that the benefits outweigh the risk. And if there is one more tool in the arsenal for treating diabetes that makes it “suck a little less,” then it is worth considering.
1) British Journal of Diabetes and Vascular Disease. 2014; 14(3):98