Comparison of HbA1c in Chinese patients with type 1 or type 2 diabetes randomized to twice daily insulin lispro low mix 25 or twice daily human insulin mix 30/70.

BACKGROUND: Glycemic control prevents onset and progression of diabetes-related long-term complications. The objective of this study was to demonstrate that twice daily insulin lispro low mix 25 is noninferior to twice daily human insulin mix 30/70 in achieving glycemic control as measured by hemoglobin A1c (HbA1c), from baseline to endpoint, in patients with type 1 or 2 diabetes. METHODS: In this phase IV, crossover, open-label, multicenter study, 117 Chinese patients with diabetes were randomly assigned to one of two treatment sequence groups. One group received 12-week treatment with twice daily human insulin mix 30/70 followed by 12-week treatment with twice daily insulin lispro low mix 25, while the other group received the reverse treatment sequence. HbA1c, baseline-to-endpoint change in HbA1c, proportion of patients achieving target HbA1c -0.3%). No statistically significant differences between treatments were observed for any of the secondary efficacy measures. The incidence of treatment-emergent adverse events and hypoglycemia between the two treatments and treatment sequence groups was similar. Three serious adverse events were reported (human insulin mix 30/70 group: 2 patients (1.7%, hypoglycemic coma and cardiac failure); insulin lispro low mix 25 group: 1 patient (0.9%, stroke)). All serious adverse events were resolved and no patients died during the study. CONCLUSION: The results support noninferiority of twice daily insulin lispro low mix 25 versus twice daily human insulin mix 30/70 in HbA1c control in Chinese patients with type 1 or 2 diabetes.