A Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial Comparing the Safety Profile of a Needle-Free Insulin Injector with Conventional Insulin Pen Injections in Chinese Patients with Type 2 Diabetes Mellitus

Background: Needle-free insulin delivery has been shown to accelerate the absorption and the action of insulin, and to be well tolerated. Objective: To determine the safety profile of a needle-free injector with that of conventional insulin pen injections in patients with T2DM. Methods: A total of 427 patients with T2DM were enrolled in a multicenter, prospective, randomized, open-label clinical trial, and were randomized 1:1 to receive basal or premixed insulin via a needle-free injector or via conventional insulin pen injections. Adverse events occurring during the study were recorded in the 2 groups, and the incidences of hypoglycemia and injection site reactions were compared. Result: The adverse events rates in the needle-free injector and insulin pen groups were 5.31% and 3.35%, respectively, but no statistically significant difference between the 2 groups (P = 0.3468). Rates of hypoglycemia (25.60% vs. 18.18%, respectively; P = 0.0671), and local injection-site reactions (bleeding/ecchymosis and redness) were also similar in the 2 groups. However, the incidence of skin scratches was decreased significantly in the needle-free injector group (15.53% vs. 23.92%; P = 0.0319). There was no new indurations observed in needle-free injector group compared 4.00% in the conventional insulin pen group (P = 0.006). Patients in the needle-free injector group also showed lower overall VAS pain scores than those in the conventional insulin pen group (mean scores, 1.11 ± 1.21 vs. 1.98 ± 1.99; P < 0.0001). Conclusion: Administration of insulin by a needle-free injector could provide a better safety profile than insulin pen injections, by reducing skin scratches, indurations, and pain. Disclosure L. Chen: Research Support; Self; Becton, Dickinson and Company. 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. Y. Wang: None. Z. Ma: None. X. Ran: None. Z. Sun: None. X. Xu: None. G. Wang: None. L. Guo: None. Z. Shan: None.