New Study Tests Liver-Targeted Insulin in Type 1 Diabetes
If you are an adult who has type 1 diabetes, you may be eligible to participate in a trial examining the impact of an investigational liver-targeted insulin on blood glucose control, A1C, and nighttime lows.
Clinical Trials Identifier: NCT06238778
Trial Name: Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec (OPTI-2)
Diabetes Type: Type 1 diabetes
Trial Sponsor: Diasome Pharmaceuticals, Inc.
What is the aim of the study?
This study is researching whether administering a liver-targeting insulin called HDV-L insulin (Hepatocyte-directed Vesicles-insulin lispro), will improve glycemic control by reducing nocturnal hypoglycemia while maintaining or improving A1C (HbA1c) in people living with type 1 diabetes.
HDV-L insulin is designed to act on the liver to enhance glucose storage and decrease the frequency of severe hypoglycemia in individuals requiring insulin. It is not currently approved for use. Results from an 2020 Diasome study called OPTI-1 indicated that HDV-L is associated with a 25% reduction in level 2 hypoglycemic events (blood glucose readings below 54 mg/dl).
In addition to measuring the incidence rate of and percentage of time experiencing level 2 hypoglycemia, the OPTI-2 study will also evaluate HDV-L’s impact on A1C, triglyceride, and liver enzyme levels when compared to the use of regular insulin lispro (such as Humalog, Admelog, or Lyumjev).
How does the trial work?
For this trial, researchers are recruiting roughly 230 adults with type 1 diabetes aged 18-79 who are on multiple daily injections (MDI). Participants will be randomized to either receive HDV-L insulin lispro (the experimental drug) or insulin lispro (the active comparator or control insulin) in combination with the basal insulin degludec (Tresiba). All participants will wear a continuous glucose monitor (CGM).
The entire trial will run nearly 8 months inclusive of a screening and follow-up periods. This will include:
- a screening period of up to 3 weeks;
- a run-in period of 2 weeks to assess eligibility and to transition to the use of insulin lispro, insulin degludec, and the Dexcom G7 CGM;
- a 12-week dose optimization period;
- a 13-week maintenance period;
- a 2-week transition follow-up period
At the conclusion of the study, participants’ CGM data will be tracked and reviewed to identify the incidence of level 2 nighttime hypoglycemic events and nocturnal Time Below Range. Researchers will also conduct blood tests to measure A1C, triglycerides, and liver enzyme levels.
Why is this study of HDV-L liver-targeted insulin important?
Hypoglycemia is a common complication for people with diabetes, particularly those who require insulin therapy. Having frequent hypoglycemic events, severe hypoglycemic events, or both can result in serious consequences, including seizures, coma, or, less commonly, death.
Hepatocyte-directed vesicle technology, which involves two-layered microscopic discs just 20-50 nanometers in size that bring insulin to liver cell receptors, is the only pharmaceutical insulin currently being tested with the objective of reducing nighttime hypoglycemia.
Are you interested in participating?
You may be eligible if you:
- Are aged 18-79 with type 1 diabetes confirmed by a blood C-peptide test result of <0.6 nmol/L
- You have been on insulin for at least 6 months
- Are willing to use a designated CGM device and forgo an insulin pump or AID device throughout the duration of the study
- Have an A1C reading between 6.5-9.0
- Use a total daily insulin dose that is 1.25 U/kg/day or less
People who have used weight loss medications, dietary supplements for weight loss, or glucose-lowering medications outside of insulin 30 days prior to the study are not eligible to participate. See a full list of inclusion and exclusion criteria here.
This study is recruiting in California, Colorado, Florida, Georgia, Illinois, Indiana, New York, North Carolina, Ohio, and Texas. To enroll or learn more about this study, contact Todd Hobbs, MD at Diasome Pharmaceuticals at [email protected] or call 216-780-9324.
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