Diabetes, Metabolic Syndrome and Obesity (Aug 2016)
Comparison of efficacy and safety of two starting insulin regimens in non-Asian, Asian Indian, and East Asian patients with type 2 diabetes: a post hoc analysis of the PARADIGM study
Abstract
Linong Ji,1 Kyung Wan Min,2 Juliana Oliveira,3 Thomas Lew,4 Ran Duan3 1Department of Endocrinology, Peking University People's Hospital, Beijing, People's Republic of China; 2Department of Endocrinology, Eulji Hospital, Seoul, Republic of Korea; 3Eli Lilly and Company, Indianapolis, IN, USA; 4Eli Lilly and Company, Taipei, Songshan District, Taiwan Objective: The objective of this study was to explore the efficacy and safety of insulin lispro mix 25 (25% insulin lispro and 75% insulin lispro protamine suspension [LM25]) or insulin glargine plus insulin lispro (G+L) in insulin-naïve patients with type 2 diabetes from different racial/ethnic groups. Methods: Three subgroups from the PARADIGM study were analyzed post hoc: non-Asian (n=130), Asian Indian (n=106), and East Asian (n=89). Results: All subgroups recorded glycated hemoglobin (HbA1c) reductions: non-Asian (LM25, -2.07%; G+L, -2.05%), Asian Indian (LM25, -1.75%; G+L, -1.60%), and East Asian (LM25, -2.03%; G+L, -1.76%); end point HbA1c values were higher in Asian Indians and East Asians than in non-Asians. Fewer Asian Indians (LM25, 43.2%; G+L, 29.2%) and East Asians (LM25, 37.5%; G+L, 36.1%) reached HbA1c ,7% versus non-Asians (LM25, 51.7%; G+L, 48.1%); differences were not significant (P=0.12 and P=0.06, respectively). The mean total daily insulin dose (U/kg) for non-Asians was 0.67 (LM25) and 0.61 (G+L), for Asian Indians was 0.91 (LM25) and 0.90 (G+L), and for East Asians was 0.53 (LM25) and 0.59 (G+L). The ratio of mealtime to total insulin dose in the G+L arm for non-Asians was 0.19±0.23, for Asian Indians was 0.33±0.25, and for East Asians was 0.34±0.27. Overall incidence (%) of hypoglycemia in non-Asians was 94.1 (LM25) and 91.8 (G+L), in Asian Indians was 90.4 (LM25) and 88.5 (G+L), and in East Asians was 69.8 (LM25) and 77.3 (G+L). Conclusion: Asian Indians showed least improvement in glycemic HbA1c reduction despite greater insulin use. East Asians and non-Asians achieved similar HbA1c reduction in the LM25 arm with a lower rate of hypoglycemia. Asians required more mealtime insulin coverage than non-Asians. This study added important insight into the effect of ethnicity on insulin treatment outcomes in patients with type 2 diabetes. Keywords: ethnicity, insulin, race, type 2 diabetes mellitus
