Pharmacokinetic Similarity between Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 and Originator Insulin Aspart Mix 70/30 (NovoMix 30) in Indian Adults with Type 2 Diabetes: GEMELLI M Substudy.

ABSTRACT:

Background

We compared the pharmacokinetic exposure, efficacy, safety and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (SAR_Asp-Mix) with its originator NovoMix^® 30 insulin aspart mix (NN-Mix) in adults with type 2 diabetes.

Methods

This was a randomized, open-label, parallel-group, substudy of the phase 3 GEMELLI M trial performed in three Indian centres. Totally 13 Indian participants previously treated with premix insulin received a single subcutaneous 0.3 U/kg dose of each treatment and underwent pharmacokinetic sampling for 16 h after dosing. Participants were then treated for 26 weeks as per the main GEMELLI M trial with efficacy, safety and immunogenicity compared between groups.

Results

The extent of exposure (are

SUBMITTER: Mohan V 

PROVIDER: S-EPMC9519840 | biostudies-literature | 2022 Jul-Aug

REPOSITORIES: biostudies-literature