Biosimilar Liraglutide Matches Reference in Weight Loss and Glycemic Control in Indian T2DM: Study
Obesity is a chronic metabolic disease of global concern, often associated with Type 2 Diabetes Mellitus (T2DM).
Global guidelines recommend a holistic approach for Type 2 Diabetes Mellitus management by addressing the associated comorbidities. Here, we have conducted a post-hoc evaluation of a Liraglutide biosimilar Phase III trial on weight reduction and glycemic benefits in Indian Type 2 Diabetes Mellitus patients with obesity in comparison to reference liraglutide.
They have conducted a post-hoc analysis of a Liraglutide biosimilar Phase III trial on weight reduction in Indian Type 2 Diabetes Mellitus patients with obesity in comparison to reference liraglutide.
We evaluated weight reduction and glycated hemoglobin (HbA1c) improvement in Indian Type 2 Diabetes Mellitus patients (Body Mass Index greater than 25 kilograms per square meter) from baseline to week 24.
Group A – Intervention arm: Liraglutide Biosimilar in Type 2 Diabetes Mellitus patients with obesity.
Group B – Control arm: Reference Liraglutide in Type 2 Diabetes Mellitus patients with obesity. The primary endpoint was the mean change in body weight from baseline to week 24.
Results: A total of 179 Type 2 Diabetes Mellitus patients (Body Mass Index greater than 25 kilograms per square meter and above) who satisfied the inclusion criteria were included in this post-hoc analysis. The mean Body Mass Index of Type 2 Diabetes Mellitus patients with obesity in the Biosimilar Liraglutide arm was 29.8 ± 4.6 kilograms per square meter, and in the Reference Liraglutide arm, it was 29.8 ± 4.8 kilograms per square meter.
A significant mean weight reduction (Mean ± Standard Deviation) of 5.5 ± 1.2 kilograms (7.3 ± 1.7%) and 7.1 ± 2.6 kilograms (8.9 ± 1.7%) (p < 0.001) was demonstrated by both biosimilar liraglutide and reference liraglutide, respectively. However, weight reduction was comparable across both groups at week 24 (p = 0.71). Likewise, glycemic parameters (glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose) significantly improved in both treatment arms (p < 0.001).
However, they were comparable across the groups at week 24 with a p-value of 0.89, 0.43, and 0.17 for glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose, respectively. Biosimilar Liraglutide at a dose of up to 1.8 milligrams was non-inferior to reference Liraglutide and resulted in significant weight reduction and glycemic control (glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose) in Indian Type 2 Diabetes Mellitus patients with obesity.
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