Patient dosing has begun in a new trial, known as ISLE-1 (InSulin Liver Effect-1), that will investigate an additive to commercially available insulin therapies.
This is a promising, new area of research that could help to reduce both hypoglycemia and hyperglycemia, which are both common concerns for people taking insulin.
The research is being conducted by Ohio-based Diasome Pharmaceuticals, which focuses on developing novel liver hepatocyte targeting systems for injectable insulin therapies.
Hepatocytes are the primary functioning cells in the liver and are associated with several metabolic functions, such as protein storage.
What is HDV therapy?
The ISLE-1 trial will assess if Hepatocyte Directed Vesicle (HDV) technology can improve the treatment of type 1 diabetes and type 2 diabetes.
HDV contains molecules that target liver hepatocytes. These molecules can be added to insulin molecules without changing the structure of insulin, and the development of HDV means that it can be added to insulin vials by pharmacists and patients on a once-per-vial basis.
Human trials have shown HDV to significantly lower post-meal glucose levels in comparison to identical amounts of untargeted commercial insulin therapy.
The ISLE-1 study
The ISLE-1 study, a phase IIb clinical trial, will evaluate the HDV system as an additive to pre-meal injected insulin therapy.
Up to 200 participants with type 1 diabetes are expected to be enrolled for a six-month period in which they will be randomised either to HDV plus a leading commercial pre-meal insulin or normal insulin treatment without HDV.
A variety of diabetes outcomes will be assessed, including overall blood glucose control, and patient dosing has already commenced.
“The initiation of this randomized study represents an important milestone for Diasome and for patients with type 1 diabetes,” said W. Blair Geho, MD, PhD, Chief Scientific Officer of Diasome Pharmaceuticals.
“The goal of the ISLE-1 study is to demonstrate that people with type 1 diabetes can achieve better and safer glucose control when a portion of their injected insulin is able to mimic the normal action of insulin from the pancreas during a meal.
“Given the fundamental and routine role of insulin in the liver in maintaining normal glycemic control, the ability to use a sophisticated and very novel liver cell targeting system as an additive to already approved insulins could provide insulin requiring patients much better overall glucose management.”

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