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Now published in The Lancet

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)

30 Pages Posted: 21 Feb 2020

See all articles by Linong Ji

Linong Ji

Peking University - Department of Endocrinology and Metabolism; Peking University People’s Hospital - Department of Endocrinology

Leili Gao

Peking University - Department of Endocrinology and Metabolism

Liming Chen

Tianjin Medical University - Metabolic Disease Hospital; Tianjin Medical University - NHC Key Laboratory of Hormones and Development

Yangang Wang

Qingdao University - Affiliated Hospital

Zhongshu Ma

Tianjin Medical University - Department of Endocrinology and Metabolism

Xingwu Ran

Sichuan University - West China Hospital

Zilin Sun

Southeast University - Department of Endocrinology

Xiangjin Xu

Government of the People's Republic of China - Fuzhou General Hospital

Guixia Wang

Jilin University (JLU) - Department of Endocrinology and Metabolism

Lixin Guo

Beijing Hospital - National Center of Gerontology, Department of Endocrinology

Zhongyan Shan

China Medical University - Department of Endocrinology and Metabolism; China Medical University - Institute of Endocrinology

More...

Abstract

Background: 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. Objective 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.

Methods: 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.

Findings: 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<0.0001). The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores.

Interpretation: Insulin therapy through needle-free injector showed a greater glycemic-lowering effect and a significantly enhanced level of patient satisfaction with insulin treatment compared with conventional insulin therapy through needle injections. In addition, the needle-free injector also had a better safety profile.

Trial registration: ClinicalTrials.gov (NCT03243903)

Funding Statement: Beijing QS Medical Technology Co., Ltd, China. This work was also supported by Grants 2016YFC1305600, 2016YFC1305603 from the Major Chronic Non-communicable Disease Prevention and Control Research.

Declaration of Interests: Linong Ji receives consulting fees from Beijing QS Medical Technology Co. He also reports grants and personal fees from Novo Nordisk, Merck, Bristol-Myers Squibb, Novartis, Sanofi, MSD, AstraZeneca, and Roche, and personal fees from Eli Lilly, Takeda, Bayer, and Boehinger Ingelheim, outside the submitted work. The other authors have nothing to disclose.

Ethics Approval Statement: Before the study was commenced, approval was received from the Ethics Committee of Peking University People’s Hospital, and the study was conducted in accordance with the moral, ethical, and scientific principles of the declaration of Helsinki and the provisions of good clinical practice (GCP) in China. Written informed consent was obtained from all participants.

Keywords: Diabetes mellitus; Efficacy; HbA1c; Insulin; Needle-free injector; Safety; Type 2

Suggested Citation

Ji, Linong and Gao, Leili and Chen, Liming and Wang, Yangang and Ma, Zhongshu and Ran, Xingwu and Sun, Zilin and Xu, Xiangjin and Wang, Guixia and Guo, Lixin and Shan, Zhongyan, 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) (February 12, 2020). Available at SSRN: https://ssrn.com/abstract=3537090 or http://dx.doi.org/10.2139/ssrn.3537090

Linong Ji (Contact Author)

Peking University - Department of Endocrinology and Metabolism ( email )

Beijing
China

Peking University People’s Hospital - Department of Endocrinology ( email )

United States

Leili Gao

Peking University - Department of Endocrinology and Metabolism

Beijing
China

Liming Chen

Tianjin Medical University - Metabolic Disease Hospital

China

Tianjin Medical University - NHC Key Laboratory of Hormones and Development ( email )

66# TongAn Rd
Tianjin, 300070
China

Yangang Wang

Qingdao University - Affiliated Hospital

Qingdao, Shandong 266000
China

Zhongshu Ma

Tianjin Medical University - Department of Endocrinology and Metabolism

Tianjin, 300052
China

Xingwu Ran

Sichuan University - West China Hospital

No 37, Guoxue Road
Wuhou District
Chengdu, Sichuan Province 610041
China

Zilin Sun

Southeast University - Department of Endocrinology ( email )

Nanjing
China

Xiangjin Xu

Government of the People's Republic of China - Fuzhou General Hospital

China

Guixia Wang

Jilin University (JLU) - Department of Endocrinology and Metabolism ( email )

China

Lixin Guo

Beijing Hospital - National Center of Gerontology, Department of Endocrinology

China

Zhongyan Shan

China Medical University - Department of Endocrinology and Metabolism ( email )

No 155, Nanjing Bei Street
Shenyang, Liaoning 110001
China

China Medical University - Institute of Endocrinology

Shenyang, Liaoning 110001
China

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