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Introduction <p>These analyses explored the efficacy and safety of once-weekly insulin icodec (icodec) in Indian participants with type&#xa0;1 or type&#xa0;2 diabetes (T1D/T2D) from the global ONWARDS&#xa0;1, 4, and 6 studies.</p> Methods <p>This was a subgroup analysis of Indian participants enrolled in the multicentre, randomised, treat-to-target phase&#xa0;3a studies: ONWARDS&#xa0;1 (insulin-naïve T2D), ONWARDS&#xa0;4 (basal-bolus treated T2D), and ONWARDS&#xa0;6 (basal-bolus treated T1D). Participants were randomised 1:1 to receive once-weekly insulin icodec or once-daily comparator insulin (glargine U100 [ONWARDS&#xa0;1 and 4] or degludec [ONWARDS&#xa0;6]). The primary outcome was change in glycated haemoglobin (HbA<sub>1c</sub>) from baseline to week&#xa0;52 for ONWARDS&#xa0;1, week&#xa0;26 for ONWARDS&#xa0;4 and 6.</p> Results <p>A total of 217 Indian participants were included. The estimated treatment differences (95% confidence interval, CI) in HbA<sub>1c</sub> change for icodec versus once-daily comparator were 0.04% [− 0.46; 0.54], − 0.04% [− 0.41; 0.32], and 0.08% [− 0.67; 0.82] in ONWARDS&#xa0;1, 4, and 6 studies, respectively. Time in range was similar between groups in the three studies. Icodec showed numerically lower rates of clinically significant hypoglycaemia compared to glargine U100 in ONWARDS&#xa0;1 and 4, though a numerically higher rate of hypoglycaemic events was noted in ONWARDS&#xa0;6 compared with degludec; results were consistent with global populations. Adverse event profiles were similar between groups, and no new safety findings were reported in the Indian subpopulation.</p> Conclusion <p>Icodec demonstrated comparable efficacy and safety to once-daily basal insulins in Indian participants with T1D and T2D. These findings support icodec as a viable option for insulin initiation or intensification in Indian clinical practice.</p> Trial Registrations <p>ONWARDS&#xa0;1: NCT04460885; ONWARDS&#xa0;4: NCT04880850; ONWARDS&#xa0;6: NCT04848480.</p>

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Efficacy and Safety of Once-Weekly Insulin Icodec in Indian Participants with Diabetes: Results from ONWARDS 1, 4, and 6 Studies

  • 期刊论文

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  • 发表日期：

    2025年10月6日

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  • Viswanathan Mohan,
  • Jothydev Kesavadev,
  • L. Sreenivasa Murthy,
  • Gayathri Anil,
  • Manu Chandrappa,
  • Soumitra Kar,
  • Sunil Mishra

摘要

Introduction

These analyses explored the efficacy and safety of once-weekly insulin icodec (icodec) in Indian participants with type 1 or type 2 diabetes (T1D/T2D) from the global ONWARDS 1, 4, and 6 studies.

Methods

This was a subgroup analysis of Indian participants enrolled in the multicentre, randomised, treat-to-target phase 3a studies: ONWARDS 1 (insulin-naïve T2D), ONWARDS 4 (basal-bolus treated T2D), and ONWARDS 6 (basal-bolus treated T1D). Participants were randomised 1:1 to receive once-weekly insulin icodec or once-daily comparator insulin (glargine U100 [ONWARDS 1 and 4] or degludec [ONWARDS 6]). The primary outcome was change in glycated haemoglobin (HbA1c) from baseline to week 52 for ONWARDS 1, week 26 for ONWARDS 4 and 6.

Results

A total of 217 Indian participants were included. The estimated treatment differences (95% confidence interval, CI) in HbA1c change for icodec versus once-daily comparator were 0.04% [− 0.46; 0.54], − 0.04% [− 0.41; 0.32], and 0.08% [− 0.67; 0.82] in ONWARDS 1, 4, and 6 studies, respectively. Time in range was similar between groups in the three studies. Icodec showed numerically lower rates of clinically significant hypoglycaemia compared to glargine U100 in ONWARDS 1 and 4, though a numerically higher rate of hypoglycaemic events was noted in ONWARDS 6 compared with degludec; results were consistent with global populations. Adverse event profiles were similar between groups, and no new safety findings were reported in the Indian subpopulation.

Conclusion

Icodec demonstrated comparable efficacy and safety to once-daily basal insulins in Indian participants with T1D and T2D. These findings support icodec as a viable option for insulin initiation or intensification in Indian clinical practice.

Trial Registrations

ONWARDS 1: NCT04460885; ONWARDS 4: NCT04880850; ONWARDS 6: NCT04848480.