Biosimilar Insulin Aspart Premix SAR341402 Mix 70/30 Versus Originator Insulin Aspart Mix 70/30 (NovoMix 30) in People with Diabetes: A 26-Week, Randomized, Open-Label Trial (GEMELLI M).

ABSTRACT:

Introduction

This study compared the efficacy, safety, and immunogenicity of biosimilar insulin aspart premix SAR341402 Mix 70/30 (SAR_Asp-Mix) with European-approved insulin aspart mix 70/30 - NovoMix® 30 (NN-Mix) in people with type 1 (T1D) or type 2 diabetes (T2D).

Methods

This 26-week, open-label, phase 3 trial enrolled 402 people with T1D (n = 105) or T2D (n = 297) previously treated with premix insulin, who were randomized (1:1) to SAR_Asp-Mix (n = 204) or NN-Mix (n = 198).

Results

After 26 weeks, the least squares (LS) mean [median] change in HbA1c from baseline was similar in both treatment groups (SAR_Asp-Mix - 0.55% [- 0.60%]; NN-Mix - 0.64% [- 0.60%]). The LS mean difference for SAR_Asp-Mix versus NN-Mix was 0.08%, wi

SUBMITTER: Aravind SR 

PROVIDER: S-EPMC9008602 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature