It’s promising news for diabetes clinical trials and research: industry giant, GI Dynamics, has successfully enrolled their first patient onto their phase 1 clinical trials. The study is set to test their product EndoBarrier©, which is a medical device that aids patients with type 2 diabetes and obesity. Though it is still early days, this “groundbreaking” clinical research is definitely something to get excited about.
Endobarrier’s clinical trials are the first of their kind to measure the primary endpoint of type 2 diabetes combined with reductions in various other health conditions. If successful, the device could effectively address issues such as obesity, cardiovascular risk, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and chronic kidney disease (CKD). Positive results would put the product in good stead for FDA approval. This, in turn, could lead to the mass distribution of a practical, non-surgical answer to reducing the impact of the disease on everyday life. The days of pinprick tests for glucose monitoring may soon be over!
All about EndoBarrier
EndoBarrier does exactly what it says on the tin. The device is a sleeve - a “barrier” - that is implanted into the upper half of the small intestine by means of an endoscopy procedure. The clever science is this: since the small intestine absorbs a lot of the nutrients from our food, the sleeve acts as a wall between food and the muscle, limiting the amount of nutrients absorbed by the body as a whole. What we observe in this intervention is genius. The particular food stuff (glucose, for instance) directly linked to hormone changes that correlate with diabetes are overlooked by the body. Early clinical studies in Europe have confirmed the theoretical results: EndoBarrier can lower blood sugar levels, making it easier for patients with type 2 diabetes to lose weight and control their condition.
Want to know more? Here’s an introductory video by GI Systems themselves that explains the device in full:
So, what’s next?
With a whole body of clinical research dating back to the start of the last century, it’s easy to wonder: why is EndoBarrier “groundbreaking?” The fact is that EndoBarrier is being championed for its simplicity amongst clinical studies of genetic mutations and chemical or hormonal intervention. Unlike Humulin or Pramlintide, EndoBarrier may produce results that could see not only control of this form of diabetic condition but a solution to tackling it in the future.
However, these kinds of results only come by extensive clinical research and human clinical trials. In order to get FDA approval, GI Systems must be sure to learn from previous, industry-made mistakes. It’s crucial that the company avoid the issues of early research into Metformin, which as a result took 70 years to develop a safe, working product. Similarly, vTv’s Azeliragon drug found positive effects among Alzheimer’s patients with type 2 diabetes but was unfortunately denied FDA approval over failing to meet the study’s pre-arranged outcomes. Ultimately, GI Systems needs to focus on balancing their ideal dreams of a miracle cure with the reality of objective (and sometimes limiting) industry-standards. Regardless of positive results, a well-organised study with achievable goals will only add to the library of knowledge on diabetes being documented and studied all around the world.
While the induction of patients into clinical trials is always positive news, it’s evident that this is only the beginning for GI Systems and EndoBarrier. Yet, with structured and ethical practice, this study may produce results that could alter our understanding of diabetes and its related conditions; and, while it’s no miracle, it is definitely something groundbreaking to get excited about.
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