News from EASD
This morning we have had some interesting news coming out of the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD) being held in Rome, Italy. The first piece of news comes from Novo Nordisk (NYSE:NVO) and their once-daily GLP-1 Liraglutide. According to data released today patients using both Liraglutide in addition to metformin and rosiglitazone achieved a mean reduction of 1.5% from their baseline HbA1c. Not surprisingly in addition to improvements in A1c patients using Liraglutide also achieved weight loss.
Diabetic Investor is not surprised by these results as we have seen them before in the studies conducted with Byetta. The fact is GLP-1 therapy works and is very effective in lowering A1c and promoting weight loss. This has been proven whether the drug is used alone or in combination with other orals agents. It’s also true that weight loss brings with it other benefits most notably improvement in blood pressure. Finally, unlike other treatments for Type 2 diabetes GLP-1 therapy is the only therapy with proven weight loss capabilities. At best other options are weight neutral (Januvia) where we see weight gain with almost every other treatment including insulin.
Given the concern over cardiovascular events and diabetes one just might think that physicians would be prescribing Byetta in record numbers. Even if there is no weight loss, which does occur, the superior A1c performance alone makes Byetta stand above other oral agents and insulin for poorly controlled Type 2 patients. One might also believe that the FDA would approve Liraglutide as patients with diabetes need more options that effectively lower A1c and promote weight loss.
Yet this whole class of drugs could be in danger due to the FDA’s overzealous reaction to Byetta usage and some isolated cases of pancreatitis. Liraglutide is also in danger as the FDA has scheduled a panel meeting to examine the drug more closely due to the Byetta issue. The FDA’s action will overshadow other good news that will likely come out from the EASD on Byetta. Until this issue is resolved it really does not matter what Amylin (NASDAQ:AMLN), Lilly (NYSE:LLY) or Novo does. Let’s just hope the FDA does not overact, examines the issue using evidence based medicine and comes to conclusion that properly addresses the concerns over pancreatitis without killing one of the most promising treatment options available to patients with Type 2 diabetes.
The other big story that emerged today came from a study published in the New England Journal of Medicine; “Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes – The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group.” The authors concluded “Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous glucose monitoring in children and adolescents.”
Before everyone begins to jump for joy and sees this study convincing insurance companies to fully reimburse CGM systems, it’s important to examine the type of patients who participated in the study. Of the 98 participants in the adult group 82 were on an insulin pump and 16 followed multiple daily injection therapy. The baseline A1c for this group was 7.6%, not far from the ADA definition of good control which is 7%. According to the study patients in the adult achieved a mean reduction in A1c of 0.53%.
First and foremost the study does not address the largest segment of the diabetes population, namely patients with Type 2 diabetes. Second, these results should surprise no one as pump patients are the most well educated group of diabetes patients. Pump patients understand what their glucose levels mean and how to use this data. They also understand the role other factors play in properly managing their diabetes. Given the level of education a pump patient goes through Diabetic Investor is actually a little disappointed in the results. Granted a mean improvement of 0.53% is nice but it is hardly earth shaking news.
The fact that only a small percentage of patients were using MDI therapy reinforces something Diabetic Investor has been saying consistently since CGM came on the scene. The biggest beneficiaries of CGM technology are insulin pump patients who just happen to be the smallest segment of the overall diabetes market. CGM technology as good as it is, must prove its worth beyond this market segment for it to be commercially successful. While Dexcom (NASDAQ:DXCM), Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) can carve out a nice little market niche with pump patients the real dollars lie elsewhere.
This does not mean there is not a place for CGM in the broader patient population. Diabetic Investor believes CGM when used properly with an educated patient can have an enormous positive impact. However, the reality of the market where the majority of patients rarely check their glucose levels or worse fail to check at all, stands in the way of CGM ever becoming the multi-billion market that conventional blood glucose monitoring is today. This is true even if insurers fully reimbursed the product for all patients both type 1 and type 2.