Lannett Initiates Human Clinical Trial of Biosimilar Insulin Glargine

Lannett announced the commencement of a human clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC). The trial, being conducted in South Africa, is the first clinical study to directly compare the Lannett/HEC insulin glargine to US Lantus® as part of the effort to file a biosimilar Biologics License Application with the U.S. Food and Drug Administration. Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar.

The clinical trial is a single center, single-dose, double-blind, randomized, two-period crossover study, designed to compare the pharmacokinetics (PK) and pharmacodynamics (PD) of the Lannett/HEC-insulin glargine to US-approved Lantus®, after a single subcutaneous dose in at least 24 healthy male adult human volunteers. In addition, a secondary objective of the trial is to assess the safety profiles of the Lannett/HEC-insulin glargine to US-Lantus® after single subcutaneous doses. Study results are expected in September 2019.

"Initiating a first-in-human clinical trial of our partnered insulin glargine product is a major milestone in the progression of this project," said Tim Crew, chief executive officer of Lannett. "We look forward to the clinical advancement of the product as an affordable treatment option, especially with 29 million Americans suffering with type 1 or type 2 diabetes."

Lantus® is a registered trademark of Sanofi S.A.

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