GP40071 (insulin aspart biosimilar) / Geropharm - LARVOL DELTA

Clinical Pharmacology of Insulin Aspart Biosimilar GP40071: Pharmacokinetic/Pharmacodynamic Comparability in Hyperinsulinemic Euglycemic Clamp Procedure. (PubMed, Clin Pharmacol Drug Dev) - "The aim of this clinical trial was to compare the pharmacokinetics and pharmacodynamics of GP40071 (GP-Asp) and NovoRapid Penfill (Novo-Asp) in a hyperinsulinemic euglycemic clamp (HEC). The safety profiles of the drugs were also comparable. Bioequivalence, similar PD, and safety of GP-Asp and Novo-Asp were demonstrated."

Clinical • Journal • PK/PD data • Diabetes • Metabolic Disorders

Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid Penfill) in Type 1 diabetes mellitus. (PubMed, J Comp Eff Res) - P3 | " GP-Asp demonstrated similar safety and efficacy. Trial registration number: NCT04079413 (ClinicalTrials.gov)."

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

Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients (clinicaltrials.gov) - P3; N=264; Completed; Sponsor: Geropharm; Active, not recruiting ➔ Completed; Trial completion date: Apr 2020 ➔ Jan 2020

Clinical • Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus