1072-P: Comparison of the Efficacy between a Needle-Free Insulin Injector and Conventional Insulin Pen in Glycemic Control in Insulin-treated Type 2 Diabetic Patients in China

Background: Needle free insulin injector is designed for diabetics with needle anxiety or fear of injection pain resulting in reluctance to initiate insulin therapy when it is actually indicated. This device has faster absorption of insulin and has better glycemic control compared with conventional insulin pen. But the efficacy of glycemic control was only evaluated by postprandial blood glucose or the area under blood glucose curve. Objective: To investigate the efficacy of needle free insulin injector by HbA1c level compared with conventional insulin pen in insulin treated type 2 diabetic patients in multicenter, prospective, randomized, open-label trial. Methods: A total of 427 patients with HbA1c levels of ≥7.5% to ≤11% while receiving basal or premixed insulin were randomized 1:1 to needle free insulin injector group (NFII) or conventional insulin pen group (CIP). The primary efficacy endpoint was change of HbA1c leve after 16 weeks treatment. The change of 7-point blood glucose profile and the percentage of patients with HbA1c level <7% were also observed. Results: Of the 412 patients (mean age 57.92±10.03ys; BMI 28.33±2.96kg/m2; HbA1c 8.25±1.00%) who completed the study, 206 patients were insulin treated via NFII and 206 via CIP. There were no significant differences in baseline characteristics between the two groups (P> 0.05). The HbA1c reduction 0.55% (95% CI: -0.71, -0.39) at week 16 in NFII group was non-inferior and statistically superior compared with that of 0.26% (95% CI: -0.42, -0.11) in CIP group. There were no differences between two groups in the percentages of patients achieving the HbA1c target (27.32% vs. 24.26%; P> 0.05) or in the change of 7-point blood glucose profile at week 16. Conclusions: The device non-inferior and statistically superior efficacy in glycemic control compared to conventional insulin pen in insulin-treated type 2 diabetic Patients in China. Disclosure L. Gao: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Roche Pharma, Sanofi. L. Guo: None. Y. Wang: None. L. Chen: Research Support; Self; Becton, Dickinson and Company. G. Wang: None. X. Ran: None. X. Xu: None. Z. Sun: None. Z. Ma: None. Z. Shan: None.