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Background <p>Obesity is a chronic metabolic disease of global concern, often associated with Type 2 Diabetes Mellitus (T2DM). Global guidelines recommend holistic approach for T2DM management by addressing the associated comorbidities. Here, we have conducted a post-hoc evaluation of Liraglutide biosimilar Phase III trial on weight reduction and glycaemic benefits in Indian T2DM patients with obesity in comparison to reference liraglutide.</p> Methods <p>We have conducted a post-hoc analysis of Liraglutide biosimilar Phase III trial on weight reduction in Indian T2DM patients with obesity in comparison to reference liraglutide. We evaluated weight reduction and HbA1c improvement in Indian T2DM patients (BMI &gt; 25&#xa0;kg/m<sup>2</sup>) from baseline to week 24. Group A – Intervention arm: Liraglutide Biosimilar in T2DM patients with obesity Group B – Control arm: Reference Liraglutide in T2DM patients with obesity. Primary endpoint was mean change in body weight from baseline to week 24.</p> Results <p>179 T2DM patients (BMI &gt; 25 Kg/m<sup>2</sup> and above) who satisfied the inclusion criteria, were included in this post-hoc analysis. The mean BMI of T2DM patients with obesity in Biosimilar Liraglutide arm was 29.8 ± 4.6&#xa0;kg/m<sup>2</sup> and that in the Reference Liraglutide arm it was 29.8 ± 4.8&#xa0;kg/m<sup>2</sup>. Significant mean weight reduction (Mean ± SD) of 5.5 ± 1.2&#xa0;kg (7.3 ± 1.7%) and 7.1 ± 2.6&#xa0;kg (8.9 ± 1.7%) (<i>p</i> &lt; 0.001) was demonstrated by both biosimilar liraglutide and reference liraglutide respectively. However, weight reduction was comparable across both the groups at week 24 (<i>p</i> = 0.71). Likewise, glycaemic parameters (HbA1c, FPG and PPG) significantly improved in both the treatment arms (<i>p</i> &lt; 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 HbA1c, FPG and PPG respectively.</p> Conclusion <p>Biosimilar Liraglutide at a dose of up to 1.8&#xa0;mg was non-inferior to reference Liraglutide and resulted in significant weight reduction and glycemic control (HbA1c, FPG and PPG) in Indian T2DM patients with obesity.</p>

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Effect of liraglutide biosimilar vs. reference liraglutide on weight reduction in T2DM patients with obesity: post hoc analysis of phase III trial

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  • 发表日期：

    2025年3月25日

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  • Sujoy Ghosh,
  • Bipin Sethi,
  • Sanjay Kalra,
  • Manash P. Baruah,
  • Abhishek Mane,
  • Sanjay Choudhari,
  • Anup Petare,
  • Mayur Jadhav,
  • Saiprasad Patil,
  • Hanmant Barkate

摘要

Background

Obesity is a chronic metabolic disease of global concern, often associated with Type 2 Diabetes Mellitus (T2DM). Global guidelines recommend holistic approach for T2DM management by addressing the associated comorbidities. Here, we have conducted a post-hoc evaluation of Liraglutide biosimilar Phase III trial on weight reduction and glycaemic benefits in Indian T2DM patients with obesity in comparison to reference liraglutide.

Methods

We have conducted a post-hoc analysis of Liraglutide biosimilar Phase III trial on weight reduction in Indian T2DM patients with obesity in comparison to reference liraglutide. We evaluated weight reduction and HbA1c improvement in Indian T2DM patients (BMI > 25 kg/m2) from baseline to week 24. Group A – Intervention arm: Liraglutide Biosimilar in T2DM patients with obesity Group B – Control arm: Reference Liraglutide in T2DM patients with obesity. Primary endpoint was mean change in body weight from baseline to week 24.

Results

179 T2DM patients (BMI > 25 Kg/m2 and above) who satisfied the inclusion criteria, were included in this post-hoc analysis. The mean BMI of T2DM patients with obesity in Biosimilar Liraglutide arm was 29.8 ± 4.6 kg/m2 and that in the Reference Liraglutide arm it was 29.8 ± 4.8 kg/m2. Significant mean weight reduction (Mean ± SD) of 5.5 ± 1.2 kg (7.3 ± 1.7%) and 7.1 ± 2.6 kg (8.9 ± 1.7%) (p < 0.001) was demonstrated by both biosimilar liraglutide and reference liraglutide respectively. However, weight reduction was comparable across both the groups at week 24 (p = 0.71). Likewise, glycaemic parameters (HbA1c, FPG and PPG) significantly improved in both the 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 HbA1c, FPG and PPG respectively.

Conclusion

Biosimilar Liraglutide at a dose of up to 1.8 mg was non-inferior to reference Liraglutide and resulted in significant weight reduction and glycemic control (HbA1c, FPG and PPG) in Indian T2DM patients with obesity.