Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog® Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data
| Autor: | Mary Anne Dellva, Elizabeth Smith Labell, Jennifer Leohr, Kallin Carter, Helle Linnebjerg |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Blood Glucose
medicine.medical_specialty medicine.medical_treatment Type 2 diabetes Pharmacokinetics Internal medicine medicine Humans Hypoglycemic Agents Insulin Insulin lispro Pharmacology (medical) Original Research Article Randomized Controlled Trials as Topic Pharmacology Type 1 diabetes Cross-Over Studies Insulin Lispro business.industry Type 2 Diabetes Mellitus medicine.disease Diabetes Mellitus Type 1 Endocrinology Postprandial Diabetes Mellitus Type 2 Onset of action business medicine.drug |
| Zdroj: | Clinical Pharmacokinetics |
| ISSN: | 1179-1926 0312-5963 |
| Popis: | Background and Objective Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This pooled analysis compared the pharmacokinetics and glucodynamics between URLi and Humalog® in healthy subjects and patients with type 1 or type 2 diabetes mellitus. Methods The analysis included four randomized, double-blind, crossover, single-dose studies (healthy subjects [n = 74], patients with type 1 diabetes [n = 78], and type 2 diabetes [n = 38]) evaluating subcutaneous doses of 7, 15, or 30 U of URLi and Humalog during an 8- to 10-h euglycemic clamp procedure. Results The pooled analysis showed an ~ 5-min faster onset of appearance, an ~8-fold greater exposure in the first 15 min, a 43% reduction in exposure beyond 3 h, and a 68-min shorter exposure duration with URLi vs Humalog across all study populations and dose range. Compared with Humalog, URLi had a 10-min faster onset of action, a 3-fold greater insulin action in the first 30 min, a 35% reduction in insulin action beyond 4 h, and a 44-min shorter duration of action across all populations and dose range. Overall exposure and insulin action were similar between URLi and Humalog for each dose level and study population. Conclusions Across the studied populations and dose range, URLi consistently demonstrated a faster absorption, reduced late exposure, and overall shorter exposure duration compared with Humalog. Similarly, URLi demonstrated earlier insulin action while reducing late insulin action and shorter insulin action compared with Humalog across the study populations and dose range. Clinical Trial Registration NCT02942654 (registered: 21 October, 2016), NCT03286751 (registered: 15 September, 2017), NCT03166124 (registered: 23 May, 2017), and NCT03305822 (registered: 5 October, 2017). |
| Databáze: | OpenAIRE |
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