A new clinical trial, known as OPTI-2, is investigating a novel liver-targeted insulin called HDV-L insulin (Hepatocyte-directed Vesicles-insulin lispro) in adults with type 1 diabetes. This study, sponsored by Diasome Pharmaceuticals, Inc., aims to assess the potential of this investigational insulin to enhance blood glucose control, reduce nighttime hypoglycemia, and improve A1C levels.
Trial Overview
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
Sponsor: Diasome Pharmaceuticals, Inc.
Study Objective
The OPTI-2 study aims to determine if HDV-L insulin, designed to target the liver, can improve glycemic control and reduce the incidence of nocturnal hypoglycemia. Unlike conventional insulin, HDV-L insulin is engineered to enhance glucose storage in the liver, potentially decreasing severe hypoglycemia events and improving overall glucose management.
How the Trial Works
Participants: Approximately 230 adults aged 18-79 with type 1 diabetes using multiple daily injections (MDI) will be recruited.
Design: Participants will be randomly assigned to receive either HDV-L insulin lispro or regular insulin lispro (a commonly used insulin) alongside the basal insulin degludec (Tresiba).
Monitoring: All participants will use a continuous glucose monitor (CGM) throughout the study.
Trial Phases:
Screening Period: Up to 3 weeks.
Run-In Period: 2 weeks to transition to insulin lispro, insulin degludec, and the Dexcom G7 CGM.
Dose Optimization Period: 12 weeks.
Maintenance Period: 13 weeks.
Transition Follow-Up: 2 weeks.
Researchers will track CGM data to evaluate the frequency of level 2 nighttime hypoglycemia and measure various biomarkers, including A1C, triglycerides, and liver enzymes.
Importance of the Study
Hypoglycemia is a significant concern for individuals with diabetes, particularly those on insulin therapy. Severe hypoglycemic episodes can lead to serious outcomes such as seizures or coma. HDV-L insulin represents a novel approach using hepatocyte-directed vesicle technology, which aims to reduce the incidence of nighttime hypoglycemia by delivering insulin specifically to liver cell receptors.
Eligibility Criteria
To qualify for participation in the study, individuals must meet the following criteria:
- Aged 18-79 with type 1 diabetes (confirmed by a blood C-peptide test result of <0.6 nmol/L).
- On insulin therapy for at least 6 months.
- Willing to use a designated CGM device and refrain from using insulin pumps or automated insulin delivery (AID) systems.
- A1C between 6.5-9.0.
- Total daily insulin dose ≤1.25 U/kg/day.
Exclusions: Recent use of weight loss medications, dietary supplements for weight loss, or non-insulin glucose-lowering medications within the past 30 days disqualifies potential participants.
Conclusion
The OPTI-2 trial could offer new insights into the management of type 1 diabetes by evaluating a liver-targeted insulin with the potential to mitigate nighttime hypoglycemia. This innovative approach may provide a valuable addition to the current options available for people with diabetes.
Related topics:
The Truth About Diabetes: Understanding the Condition and Its Impact
Study Reveals Type 1 Diabetes Affects Taste and Flavor Recognition
Imeglimin for Type 2 Diabetes Mellitus: Its Efficacy and Insight Into the Potential Benefit for Renal and Liver Function