Scholarlink

Introduction <p>This post hoc analysis of an A Toujeo<sup>®</sup> Observational Study (ATOS) aims to evaluate the real-world effectiveness and safety of insulin glargine 300&#xa0;U/ml (Gla-300) in high-risk subgroups of insulin-naïve people with type 2 diabetes (PwT2D) from multiple geographical regions (Asia, the Middle East, North Africa, Latin America, and Eastern Europe).</p> Methods <p>In these post hoc analyses of ATOS, a real-world, 12-month, prospective study included 4422 insulin-naïve adults (age ≥ 18&#xa0;years) with type 2 diabetes (T2D) uncontrolled (HbA<sub>1c</sub> &gt; 7% and ≤ 11%) on one or more oral antidiabetic drugs (OADs) who initiated Gla-300 treatment as per routine practice. Primary and secondary endpoints were studied according to renal impairment (RI) status (without or with) and age group (&lt;/≥ 70&#xa0;years).</p> Results <p>At baseline, participants with a history of RI (<i>N</i> = 581, 13.1%) and older participants (aged ≥ 70&#xa0;years, <i>N</i> = 514, 11.6%) had a longer duration of diabetes and were more likely to present diabetic complications compared to without RI and younger participants (aged &lt; 70&#xa0;years). At month 6, the individualized HbA<sub>1c</sub> target (as determined by their treating physician) was achieved in 27.5% of participants with RI compared to 24.8% of participants without RI whereas 32.3% of older participants achieved their individualized HbA<sub>1c</sub> target compared to 24.2% of younger participants. In this post hoc analysis, Gla-300 treatment improved glycemic control with meaningful reductions in HbA<sub>1c</sub>, fasting plasma glucose (FPG) and fasting self-monitored blood glucose (SMBG) across all subgroups. The incidence of hypoglycemia was low and changes in body weight were minimal across all subgroups.</p> Conclusions <p>In a real-world setting, the initiation of Gla-300 in insulin-naïve PwT2D uncontrolled on OADs resulted in improved glycemic control with a low incidence of hypoglycemia and minimal weight change in participants with a history of RI and in older participants.</p> Trial Registration <p>Clinicaltrials.gov number NCT03703869.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Effectiveness and Safety of Insulin Glargine 300 U/ml in High-Risk Subgroups (Renal Impairment and Older Age ≥ 70 years) of Insulin-Naïve People with Type 2 Diabetes: A Post hoc Analysis of Real-World ATOS Study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月8日

查看全文
  • Amir Tirosh,
  • Niaz Khan,
  • Hernando Vargas-Uricoechea,
  • Gagik Galstyan,
  • Abdul Rahman Al Shaikh,
  • Brij Mohan Makkar,
  • Maria Aileen Mabunay,
  • Lydie Melas-melt,
  • Valerie Pilorget,
  • Janaka Karalliedde

摘要

Introduction

This post hoc analysis of an A Toujeo® Observational Study (ATOS) aims to evaluate the real-world effectiveness and safety of insulin glargine 300 U/ml (Gla-300) in high-risk subgroups of insulin-naïve people with type 2 diabetes (PwT2D) from multiple geographical regions (Asia, the Middle East, North Africa, Latin America, and Eastern Europe).

Methods

In these post hoc analyses of ATOS, a real-world, 12-month, prospective study included 4422 insulin-naïve adults (age ≥ 18 years) with type 2 diabetes (T2D) uncontrolled (HbA1c > 7% and ≤ 11%) on one or more oral antidiabetic drugs (OADs) who initiated Gla-300 treatment as per routine practice. Primary and secondary endpoints were studied according to renal impairment (RI) status (without or with) and age group (</≥ 70 years).

Results

At baseline, participants with a history of RI (N = 581, 13.1%) and older participants (aged ≥ 70 years, N = 514, 11.6%) had a longer duration of diabetes and were more likely to present diabetic complications compared to without RI and younger participants (aged < 70 years). At month 6, the individualized HbA1c target (as determined by their treating physician) was achieved in 27.5% of participants with RI compared to 24.8% of participants without RI whereas 32.3% of older participants achieved their individualized HbA1c target compared to 24.2% of younger participants. In this post hoc analysis, Gla-300 treatment improved glycemic control with meaningful reductions in HbA1c, fasting plasma glucose (FPG) and fasting self-monitored blood glucose (SMBG) across all subgroups. The incidence of hypoglycemia was low and changes in body weight were minimal across all subgroups.

Conclusions

In a real-world setting, the initiation of Gla-300 in insulin-naïve PwT2D uncontrolled on OADs resulted in improved glycemic control with a low incidence of hypoglycemia and minimal weight change in participants with a history of RI and in older participants.

Trial Registration

Clinicaltrials.gov number NCT03703869.