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

Mar 8, 2025Advances in therapy

Safety of iGlarLixi in Japanese People with Type 2 Diabetes After Market Approval

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Abstract

In a cohort of 438 individuals switched to iGlarLixi, there were zero events of hospital-treated hypoglycaemia.

The incidence rate of hospital-treated hypoglycaemia was 0.011 events per person-year in the iGlar-100 group.
No cases of severe hyperglycaemia requiring inpatient treatment were observed in any of the evaluated cohorts.
Cohort 1 had a median follow-up duration of 52 days for the iGlarLixi group and 44 days for the iGlar-100 group.
Cohort 2A, which included patients switched from GLP-1 RA ± oral antidiabetic drugs, had a median follow-up of 76 days.
Cohort 2B included patients switched from GLP-1 RA and long-acting insulin ± oral antidiabetic drugs, with a median follow-up of 73 days.

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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.

Key numbers

Incidence of Hospital-Treated Hypoglycaemia

Cohort 1, newly prescribed iGlarLixi over 52 days median follow-up.

0.011

Incidence of Hospital-Treated Hypoglycaemia for iGlar-100

Cohort 1, over a median follow-up of 44 days.

9726

Number of Participants in Cohort 1

Including 438 newly prescribed iGlarLixi and 9295 iGlar-100.

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

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