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Introduction <p>In this post-marketing study in Japan, the occurrence of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment was evaluated in various cohorts of people with type 2 diabetes (T2D) newly switched to iGlarLixi, a titratable, once-daily, fixed-ratio combination of long-acting insulin glargine 100 U/mL (iGlar-100) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA, lixisenatide).</p> Methods <p>In this retrospective, observational study, acute-care hospital data from adults with T2D were analysed from the Medical Data Vision database. In Cohort 1, the incidence rate of hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus iGlar-100 was assessed. Cohort 2 was subdivided to evaluate the incidence rate of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment in people switched to iGlarLixi from either a GLP-1 RA&#xa0;±&#xa0;oral antidiabetic drugs (OADs) or OADs alone (Cohort 2A) or from a GLP-1 RA and long-acting insulin&#xa0;±&#xa0;OADs or long-acting insulin&#xa0;±&#xa0;OADs (Cohort 2B).</p> Results <p>Of the 438 people in the iGlarLixi group and 9295 people in the iGlar-100 group in Cohort 1, who had a median follow-up duration of 52 and 44&#xa0;days, respectively, there were zero and 0.011 (95% CI 0.006–0.018) events per person-year of hospital-treated hypoglycaemia, respectively. Cohort 2A included 201 people each in the GLP-1 RA&#xa0;±&#xa0;OADs and OADs alone groups, with a median follow-up duration of 76 and 101&#xa0;days, respectively, and Cohort 2B included 255 people in the GLP-1 RA and long-acting insulin&#xa0;±&#xa0;OADs group and 623 people in the long-acting insulin&#xa0;±&#xa0;OADs group, with a median follow-up duration of 73 and 62&#xa0;days, respectively; no cases of hospital-treated hypoglycaemia or severe hyperglycaemia requiring inpatient treatment were observed.</p> Conclusion <p>Consistent with clinical trials, this post-marketing database study observed that newly prescribed iGlarLixi has a low risk of serious hypoglycaemia or hyperglycaemia in Japanese people with T2D, irrespective of prior antidiabetic drug treatment.</p>

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Safety of iGlarLixi in Japanese People with Type 2 Diabetes: A Post-marketing Database Study

  • 期刊论文

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  • 发表日期：

    2025年3月8日

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  • Hideaki Kaneto,
  • Makiko Hatanaka,
  • Yukiko Morimoto,
  • Yoko Takahashi,
  • Yasuo Terauchi

摘要

Introduction

In this post-marketing study in Japan, the occurrence of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment was evaluated in various cohorts of people with type 2 diabetes (T2D) newly switched to iGlarLixi, a titratable, once-daily, fixed-ratio combination of long-acting insulin glargine 100 U/mL (iGlar-100) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA, lixisenatide).

Methods

In this retrospective, observational study, acute-care hospital data from adults with T2D were analysed from the Medical Data Vision database. In Cohort 1, the incidence rate of hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus iGlar-100 was assessed. Cohort 2 was subdivided to evaluate the incidence rate of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment in people switched to iGlarLixi from either a GLP-1 RA ± oral antidiabetic drugs (OADs) or OADs alone (Cohort 2A) or from a GLP-1 RA and long-acting insulin ± OADs or long-acting insulin ± OADs (Cohort 2B).

Results

Of the 438 people in the iGlarLixi group and 9295 people in the iGlar-100 group in Cohort 1, who had a median follow-up duration of 52 and 44 days, respectively, there were zero and 0.011 (95% CI 0.006–0.018) events per person-year of hospital-treated hypoglycaemia, respectively. Cohort 2A included 201 people each in the GLP-1 RA ± OADs and OADs alone groups, with a median follow-up duration of 76 and 101 days, respectively, and Cohort 2B included 255 people in the GLP-1 RA and long-acting insulin ± OADs group and 623 people in the long-acting insulin ± OADs group, with a median follow-up duration of 73 and 62 days, respectively; no cases of hospital-treated hypoglycaemia or severe hyperglycaemia requiring inpatient treatment were observed.

Conclusion

Consistent with clinical trials, this post-marketing database study observed that newly prescribed iGlarLixi has a low risk of serious hypoglycaemia or hyperglycaemia in Japanese people with T2D, irrespective of prior antidiabetic drug treatment.