HDV insulin lispro (HDV-L) / Diasome - LARVOL DELTA

Hepatic-directed insulin lispro reduces hypoglycaemia risk in adults with type 1 diabetes compared to insulin lispro (OPTI-2 study) (EASD 2026) - P2 | "HDV-L was associated with reductions in clinically meaningful hypoglycemia, including severe hypoglycemia, while preserving glycemic control in people with type 1 diabetes using MDI. These data support advancement into Phase 3 studies."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

OPTI-2: Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec (clinicaltrials.gov) - P2 | N=227 | Completed | Sponsor: Diasome Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Hepatic-Directed Insulin Lispro (HDV-L) Reduces Hypoglycemia Risk in Adults with Type 1 Diabetes Compared with Insulin Lispro (OPTI-2 Study) (ADA 2026) - "HDV-L associated with reductions in clinically meaningful hypoglycemia, including severe hypoglycemia, while preserving glycemic control in people with T1D using MDI. These data support advancement into Phase 3 studies."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

OPTI-2: Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec (clinicaltrials.gov) - P2 | N=227 | Active, not recruiting | Sponsor: Diasome Pharmaceuticlas, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2025 ➔ Oct 2025

Enrollment closed • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

OPTI-2: Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec (clinicaltrials.gov) - P2 | N=230 | Recruiting | Sponsor: Diasome Pharmaceuticlas, Inc. | Trial completion date: Mar 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Trial completion date • Trial primary completion date • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

OPTI-2: Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec (clinicaltrials.gov) - P2 | N=230 | Recruiting | Sponsor: Diasome Pharmaceuticlas, Inc.

New P2 trial • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus

Divergent Hypoglycemic Effects of Hepatic-Directed Prandial Insulin: A Six-Month Phase 2b Study in Type 1 Diabetes. (PubMed, Diabetes Care) - "Hepatic biodistribution of HDV-L appears to potentiate insulin effect in T1D, with divergent clinical outcomes in hypoglycemia dependent on baseline A1C."

Journal • P2b data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec (clinicaltrials.gov) - P2; N=61; Completed; Sponsor: Diasome Pharmaceuticals; Recruiting ➔ Completed

Clinical • Trial completion

Divergent Hypoglycemic Effects of Hepatic Directed Prandial Insulin: A 6-Month Study in Type 1 Diabetes Mellitus (T1DM) (ADA 2019) - "We assessed injections of HDV-insulin lispro (HDV-L) vs. insulin lispro (LIS) in T1DM in a 26-week, multicenter, randomized, double-blind trial of 176 subjects (randomized 2:1 HDV-L:LIS) with A1C 7.0-10.5% treated with basal insulin glargine or degludec. No hepatic safety signals were identified. We conclude that of HDV-L is non-inferior to LIS and its liver-targeted component potentiates insulin effect."

Divergent Hypoglycemic Effects of Hepatic Directed Prandial Insulin: A 6-Month Study in Type 1 Diabetes Mellitus (T1DM) (ADA 2019) - "We assessed injections of HDV-insulin lispro (HDV-L) vs. insulin lispro (LIS) in T1DM in a 26-week, multicenter, randomized, double-blind trial of 176 subjects (randomized 2:1 HDV-L:LIS) with A1C 7.0-10.5% treated with basal insulin glargine or degludec. No hepatic safety signals were identified. We conclude that of HDV-L is non-inferior to LIS and its liver-targeted component potentiates insulin effect."

Comparison of Different Insulin Dosing Algorithms Using Hepatic Directed Vesicle-Insulin Lispro and Insulin Degludec (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Diasome Pharmaceuticals

Clinical • New P2 trial