Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study)

• Published in: EClinicalMedicine 2020-06, Vol.23, p.100368-100368, Article 100368
• Main Authors: Ji, Linong, Gao, Leili, Chen, Liming, Wang, Yangang, Ma, Zhongshu, Ran, Xingwu, Sun, Zilin, Xu, Xiangjin, Wang, Guixia, Guo, Lixin, Shan, Zhongyan
• Format: Article
• Language: English
• Subjects: Diabetes Mellitus; Efficacy; HbA1c; Insulin; Needle-free injector; Research paper; Safety; Type 2
• ISSN: 2589-5370; 2589-5370
• DOI: 10.1016/j.eclinm.2020.100368

Insulin therapy is poorly accepted by patients with type 2 diabetes mellitus (T2DM). A needle-free insulin injector has been developed for patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. The objective of this trial was to evaluate the glucose-lowering effect, tolerability, patient satisfaction and compliance with insulin treatment via a needle-free insulin injector (NFII) compared with insulin treatment via a conventional insulin pen (CIP) in patients with T2DM. A total of 427 patients with T2DM were enrolled in a prospective, multicenter, randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks’ treatment with basal insulin or premixed insulin administered either by a NFII or CIP. ClinicalTrials.gov (NCT03243903). In the 412 patients who completed the study, the adjusted mean reduction of HbA1c from baseline at week 16 in the NFII group was 0.55% (95% CI −0.71, −0.39), which was non-inferior and statistically superior to the HbA1c reduction in the CIP group (0.26%, 95% CI −0.42, −0.11). Patients in the NFII group showed significantly higher treatment satisfaction scores than those in the CIP group (mean scores, 8.17 ± 1.78 vs. 7.21 ± 2.22, respectively; p