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

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). 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). 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. 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. The goal of type 2 diabetes (T2D) treatment is to manage blood glucose levels and to reduce the risk of diabetes-related complications. In addition to oral antidiabetic drugs (OADs), T2D can be effectively managed using combination therapy with an insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA), such as insulin glargine 100 U/mL plus lixisenatide (also known as iGlarLixi); however, these injectable drugs carry risks of hypoglycaemia and hyperglycaemia. In this study, these risks were evaluated in people who were newly prescribed iGlarLixi in Japan and enrolled in a large hospital database. Individuals were divided into various groups; in Cohort 1, hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus insulin glargine 100 U/mL (iGlar-100), with or without OADs, was assessed; in Cohort 2, we evaluated hospital-treated hypoglycaemia and severe hyperglycaemia in people who switched to iGlarLixi from a GLP-1 RA with/without OADs or OADs alone (Cohort 2A), or from a GLP-1 RA and long-acting insulin with/without OADs or long-acting insulin with/without OADs (Cohort 2B). In Cohort 1, hospital-treated hypoglycaemia occurred in none of the 438 people in the iGlarLixi group and 14 of the 9295 people in the iGlar-100 group after a median follow-up of 52 and 44 days, respectively. In Cohort 2A (402 people) and Cohort 2B (878 people), there were no occurrences of hospital-treated hypoglycaemia or hyperglycaemia after a median follow-up of 101 and 73 days, respectively. We concluded that newly prescribed iGlarLixi has a low risk of serious hypoglycaemia or hyperglycaemia in Japanese people with T2D, irrespective of their prior antidiabetic treatment.