Diasome Pharmaceuticals researched insulin’s new technology. This research aimed to see how HDV insulin can affect the liver if injected.
The goal was to inject insulin while the participants in the experiment eat their meals. This treatment used on those with diabetes type 1, lasted for six months.
The number of this trial is NCT02794155.
The Object of the Experiment
Researchers will test the effects that HDV insulin has on A1c, body weight, hypoglycemia, insulin dose, and the fasting of blood glucose levels.
Why Is This Necessary?
The technology called Hepatocyte Directed Vesicle or HDV is composed of tiny molecules that are connected directly to the insulin. Their function is to deliver insulin to the liver. The reason why the liver is so important is that the liver has cells that can store and emit glucose.
Moreover, they let the other tissues use the glucose they emit as a response to the injected or pancreatic insulin. However, when glucose is released, these cells are not exposed to the hormone. This hormone is also known as glucagon.
As a result, the cells can’t emit their already stored glucose and fight low blood sugar. Besides, only a small amount of insulin injected into the system ever reaches the liver. So, the other tissues are vulnerable. But, for those who don’t have diabetes, the liver works differently.
It can use up to 80% of the entire insulin production in the pancreas. Therefore, they can easily store their glucose and counteract the low blood sugar. So, this is the reason why this research focuses on the new technology and the effects it can have on the liver.
Besides, if the researchers focus directly on the liver during mealtime, they can see how the body naturally reacts to the production of insulin in the system. Some of them think that this kind of procedure can help stabilize weight gain and lower the risk of hypoglycemia.
When it comes to safety, according to previous research that focused on the same issue, there were some problems. Thus the testing was delayed. As a result, Lilly Diabetes made a new form of basal insulin for those with diabetes type 2.
Nevertheless, issues with liver enzymes stopped the development. So, this is where Diasome comes in with the new HDV technology. They focus on the liver and how it reacts during meal and pre-meal times.
Therefore, the trial was limited solely to the injection of insulin into the system.
How Long Does the Research Last: 6 ½ Months
Location: At 14 locations CO, GL, GA, CA, NV, WA, ID, and OK
How Can People Participate?
- If 18 years old or more;
- If have diabetes type 1 for 1 year at least;
- With BMI under 35 kg/m2;
- If use basal insulin such as detemir (Levemir) or glargine (Lantus);
- If have ave A1c between 7%-10.5%;
- If consume around two to four doses of the bolus, as a form of normal insulin during meals. Such examples are Novolog, Humulin, Humalog, and Apidra.
Source: Healio | Clinical Trials | NCBI
