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Introduction <p>The clinical benefits of insulin glargine 300 U/ml (Gla-300) have been confirmed in randomized clinical trials (EDITION and BRIGHT) and real-world studies (ATOS, Toujeo-1, and ORION) in different regions of the world. However, safety data for the Indian population are lacking. The current post-marketing surveillance study evaluated the safety and efficacy of Gla-300 in people with type 2 diabetes (T2D) from India.</p> Methods <p>SAFEGUARD was a multicenter, phase 4, single-arm, open-label, 24-week study conducted at 15 centers across India between August 10, 2021 and December 26, 2022. The study included insulin-naïve participants (aged ≥ 18 years) with T2D uncontrolled (HbA1c ≥ 7.5% and ≤ 10%) on oral anti-hyperglycemic drugs. The primary endpoint was the percentage of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and hypoglycemic episodes.</p> Results <p>Of the 220 participants included, 218 (36.8% female) were eligible for efficacy analysis. The mean ± standard deviation age was 54.0 ± 9.6 years, the baseline HbA1c was 8.8 ± 0.9%, and the duration of T2D was 9.3 ± 7.0 years. Among the 220 participants who took at least one dose of Gla-300, 24.5% (<i>n</i> = 54) reported 64 TEAEs, which included one (0.5%) SAE. The most reported event was infections (10.9%). In total, 29.5% of participants (<i>n</i> = 65) reported a level 1 hypoglycemic event, and 27.7% of participants (<i>n</i> = 18) reported the main symptom of sweating. Glycemic control improved with reductions in mean HbA1c levels (− 1.14 ± 1.2%), fasting plasma glucose (− 37.0 ± 59.3 mg/dl), and fasting self-monitored blood glucose (− 52.0 ± 44.1 mg/dl) from baseline to week 24.</p> Conclusions <p>Gla-300 was well tolerated with improved glycemic control and a low hypoglycemia risk in insulin-naïve people with T2D living in India.</p> Trial Registration <p><i>Clinical Trials Registr</i>y—India (CTRI number): CTRI/2021/07/035244. <i>WHO identifier number</i>: U1111-1255-5143. <i>NCT number</i>: NCT04980027.</p>

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Multicenter, Phase 4 Clinical Study from India to Evaluate the Safety and Efficacy of Insulin Glargine 300 U/ml in Insulin-Naïve People with Type 2 Diabetes Uncontrolled on Oral Anti-hyperglycemic Drugs: SAFEGUARD Study

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  • 发表日期：

    2025年5月8日

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  • Viswanathan Mohan,
  • Bipin Sethi,
  • Sunil M. Jain,
  • Rakesh Sahay,
  • Balamurugan Ramanathan,
  • Sreenivasa Murthy,
  • Kiran Pal Singh,
  • Shalini Menon,
  • Arvind Gadekar,
  • Vaibhav Salvi,
  • Kedar Gandhi

摘要

Introduction

The clinical benefits of insulin glargine 300 U/ml (Gla-300) have been confirmed in randomized clinical trials (EDITION and BRIGHT) and real-world studies (ATOS, Toujeo-1, and ORION) in different regions of the world. However, safety data for the Indian population are lacking. The current post-marketing surveillance study evaluated the safety and efficacy of Gla-300 in people with type 2 diabetes (T2D) from India.

Methods

SAFEGUARD was a multicenter, phase 4, single-arm, open-label, 24-week study conducted at 15 centers across India between August 10, 2021 and December 26, 2022. The study included insulin-naïve participants (aged ≥ 18 years) with T2D uncontrolled (HbA1c ≥ 7.5% and ≤ 10%) on oral anti-hyperglycemic drugs. The primary endpoint was the percentage of participants with treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) and hypoglycemic episodes.

Results

Of the 220 participants included, 218 (36.8% female) were eligible for efficacy analysis. The mean ± standard deviation age was 54.0 ± 9.6 years, the baseline HbA1c was 8.8 ± 0.9%, and the duration of T2D was 9.3 ± 7.0 years. Among the 220 participants who took at least one dose of Gla-300, 24.5% (n = 54) reported 64 TEAEs, which included one (0.5%) SAE. The most reported event was infections (10.9%). In total, 29.5% of participants (n = 65) reported a level 1 hypoglycemic event, and 27.7% of participants (n = 18) reported the main symptom of sweating. Glycemic control improved with reductions in mean HbA1c levels (− 1.14 ± 1.2%), fasting plasma glucose (− 37.0 ± 59.3 mg/dl), and fasting self-monitored blood glucose (− 52.0 ± 44.1 mg/dl) from baseline to week 24.

Conclusions

Gla-300 was well tolerated with improved glycemic control and a low hypoglycemia risk in insulin-naïve people with T2D living in India.

Trial Registration

Clinical Trials Registry—India (CTRI number): CTRI/2021/07/035244. WHO identifier number: U1111-1255-5143. NCT number: NCT04980027.