Efficacy and safety of once‐weekly semaglutide in Japanese individuals with type 2 diabetes by baseline age and body mass index. Issue 7 (9th March 2022)

• Record Type: Journal Article
• Authors: Yabe, Daisuke; Yamada, Yuichiro; Kaku, Kohei; Nishida, Tomoyuki; Sato, Toshihiro; Seino, Yutaka
• Is Part Of: Journal of diabetes investigation. Volume 13:Issue 7(2022)
• Page Start: 1161
• Page End: 1174
• Publication Date: 2022-03-09
• Subjects: Body mass index -- Diabetes mellitus -- type 2 -- Glucagon‐like peptide‐1; Diabetes -- Periodicals; Diabetes -- Research -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1111/jdi.13773
• Languages: English
• ISSNs: 2040-1116

Abstract

Abstract: Aims/Introduction: Many East Asians with type 2 diabetes are elderly and have a low body mass index (BMI), especially in 'super‐aged' populations, such as Japan. This post‐hoc analysis assessed once‐weekly semaglutide efficacy and safety in Japanese individuals with type 2 diabetes across baseline age and BMI subgroups. Materials and Methods: Data were derived from the Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) Japan monotherapy and SUSTAIN Japan oral antidiabetes drug (OAD) combination trials comparing once‐weekly semaglutide with sitagliptin or OADs, respectively. Participants were grouped by baseline age (<65 and ≥65 years) and/or BMI (<25 and ≥25 kg/m 2 ). Reductions from baseline in glycosylated hemoglobin and bodyweight (efficacy), and adverse events (safety) were assessed. Results: In this analysis, participants from the SUSTAIN Japan monotherapy trial ( n = 308; n per subgroup; range, 8–73) and SUSTAIN Japan OAD combination trial ( n = 601; n per subgroup; range, 20–168) were included. Reductions in glycosylated hemoglobin and bodyweight were numerically greater with semaglutide versus comparators across all age and BMI subgroups. Reductions from baseline in glycosylated hemoglobin ranged from –1.7 to –2.1 with semaglutide 0.5 mg, –1.8 to –2.4 with semaglutide 1.0 mg and –0.6 to –1.0 with comparators. Corresponding ranges for bodyweight (kg) were –1.0 to –2.5, –2.4 to –4.3 and 1.0 to –1.0 kg, respectively. The safety profile of semaglutide was broadly similar across BMI and age subgroups. Conclusions: In this post‐hoc analysis with modest subgroup numbers, once‐weekly semaglutide appeared consistently more efficacious versus comparators across age and BMI subgroups in Japanese patients, with a similar safety profile. Abstract : In this post‐hoc analysis of data from the Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) Japan monotherapy and SUSTAIN Japan oral antidiabetes drug combination trials, which compared once‐weekly semaglutide with sitagliptin or oral antidiabetes drugs, respectively, individuals with type 2 diabetes were grouped by baseline age (<65 and ≥65 years) and/or body mass index (<25 and ≥25 kg/m 2 ). In Japanese patients with type 2 diabetes, once‐weekly semaglutide appeared to be more efficacious versus comparators in terms of reductions in glycosylated hemoglobin and bodyweight across age, body mass index and age plus body mass index subgroups, with a similar safety profile. These exploratory results are consistent with those from other trials in the SUSTAIN clinical trial program.