1256-OR: Hepatic-Directed Insulin Lispro (HDV-L) Reduces Hypoglycemia Risk in Adults with Type 1 Diabetes Compared with Insulin Lispro (OPTI-2 Study)

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Hepatic-Directed Insulin Lispro (HDV-L) reduces the risk of clinically meaningful hypoglycemia while maintaining non-inferior glycemic control compared to standard insulin lispro in adults with Type 1 Diabetes. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Klara R. Klein; LIANA K. BILLINGS; JOHN B. BUSE; Satish Garg; Ruth Weinstock; WALTER B. GEHO; Horacio Plotkin; DOUGLAS MUCHMORE; Caroline El Sanadi; J. LINCOLN CHAPIN; JOHN ILGENFRITZ; ROBERT GEHO; PAUL S. STRUMPH

doi:10.2337/db26-1256-or

June 7, 2026Diabetes

1256-OR: Hepatic-Directed Insulin Lispro (HDV-L) Reduces Hypoglycemia Risk in Adults with Type 1 Diabetes Compared with Insulin Lispro (OPTI-2 Study)

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Key Points

This study evaluates the efficacy of hepatic-directed insulin lispro (HDV-L) in reducing hypoglycemia risk while maintaining glycemic control in adults with Type 1 Diabetes.
Conducted a 25-week double-blind Phase 2b trial with 226 adults with Type 1 Diabetes treated with multiple daily injections (MDI).
Participants were randomized 1:1 to receive either insulin lispro or HDV-L for 12 weeks of optimization and 13 weeks of maintenance therapy.
Continuous glucose monitoring (CGM) was utilized to assess glycemic outcomes throughout the trial.
HDV-L was non-inferior to insulin lispro in reducing A1C levels.
A significant reduction in hypoglycemic events was observed during the maintenance period, with 0 severe hypoglycemic events in the HDV-L group compared to 5 in the insulin lispro group (p=0.0598).
Fewer serious treatment emergent adverse events were reported in the HDV-L group (1) compared to the insulin lispro group (8).

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Implication

Demonstrates improved hypoglycemia outcomes in adults with Type 1 Diabetes using hepatic-directed insulin.

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Klein et al. (2026) studied this question.

synapsesocial.com/papers/6a27adb0a963992e16267c8c https://doi.org/10.2337/db26-1256-or

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1256-OR: Hepatic-Directed Insulin Lispro (HDV-L) Reduces Hypoglycemia Risk in Adults with Type 1 Diabetes Compared with Insulin Lispro (OPTI-2 Study)

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Discussion

Cite This Study

1256-OR: Hepatic-Directed Insulin Lispro (HDV-L) Reduces Hypoglycemia Risk in Adults with Type 1 Diabetes Compared with Insulin Lispro (OPTI-2 Study)

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Implication

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Cite This Study

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