Some of you may have seen the headlines this week about JDRF and Amylin investigating a new diabetes treatment — essentially a mixture of insulin and pramlintide (brand name Symlin), two substances that are only FDA approved for entirely separate use at the moment. Interesting!
The reasoning seems highly practical: "A co-formulated therapy that harnesses the benefit of both hormones might better mimic the natural physiology of the pancreas and simplify dosing decisions."
Also in the press release, Dr. Matthew Riddle, endocrinologist and researcher at Oregon Health & Science University is quoted as saying: "Ultimately, it might reduce the complexity of daily treatment for patients who are working hard to manage this disease, and improve their ability to achieve treatment goals."
Less juggling of separate doses that often collide to create frequent hypogylcemia? Yeah, I'd say that might do a bit to reduce complexity for us patients, ay?!
The announcement says the two organizations "have entered into a research collaboration agreement to provide financial support for a series of clinical studies to investigate the feasibility" of using this mix for treating type 1 diabetes.
So what about these studies? That's what we wanted to know. Here's the info we were able to squeeze out of JDRF's Media Relations Manager Joana Casas at the moment, FYI — assuming you're all as curious as we are.
DM) What do you mean by "proof-of-concept" studies in this case? Will these trials be conducted in animals first?
JC) In this case, the studies will comprise of up to three clinical studies in human subjects with type 1 diabetes. The studies will collectively help determine if a fixed ratio of pramlintide:insulin (established earlier through formulation development and modeling work) can improve glucose control and optimize treatment of type 1 diabetes compared with insulin treatment alone. If pramlintide/insulin co-formulation is feasible and all the studies demonstrate positive results, it is our plan to evaluate the development of a co-formulation of insulin and pramlintide for type 1 diabetes. This program does not include any work in animal models.
Will study participants get the mixed formula as an injection, or via an insulin pump?
The proof-of-concept approach in these initial studies means researchers will evaluate both vial/syringe delivery and infusion/pump delivery. It is too early to predict what the final delivery device would look like for a commercial product.
People are going to be really excited to be part of these studies. Are you recruiting now? What is the timeframe?
Work within this research collaboration is expected to begin this quarter (Q2 2011), but it is too early to be able to comment on specifics regarding the clinical trials. The names of the academic research institutions (participating) are not available at this time. It is estimated to take up to four years to complete all studies.
It's important to note that many patients with type 1 diabetes already experience the benefits of insulin and pramlintide, as separate therapies, on a daily basis to stabilize their blood sugar levels so they spend more time in the normal glucose range.
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Dern! We'd have liked to have known more NOW too. Naturally, we'll keep you all informed as these combo-therapy studies unfold.