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Abstract
Objective
This phase 3 confirmatory diabetes mellitus treatment study compared the safety and efficacy of Rapilin and NovoRapid insulin asparts in combination with metformin.
Methods
This 24-week, open-label, randomized, active-controlled, noninferiority phase 3 confirmatory study conducted across centers in China aimed to enroll patients with type 2 diabetes mellitus and blood sugar glucose inadequately controlled by oral antidiabetic drugs. Randomized patients received subcutaneous mealtime Rapilin or NovoRapid (3:1) injections, with metformin. The primary objectives were to demonstrate noninferiority (margin of 0.4%) in HbA1c change from baseline and compare safety profiles of Rapilin versus NovoRapid after 24 weeks. Secondary outcomes included 2-h postprandial plasma glucose (PPG), fasting plasma glucose (FPG), and patients achieving HbA1c <7.0% and ≤6.5%.
Results
590 patients with type 2 diabetes mellitus were randomized to Rapilin (n = 441) and NovoRapid (n = 149) groups. After 24 weeks, the mean HbA1c change from baseline was −2.20% (Rapilin) and −2.32% (NovoRapid); the estimated treatment difference based on least-square means was 0.04% (95% CI: −0.17, 0.26), meeting the noninferiority criteria for Rapilin versus NovoRapid. Comparable improvements were reported for mean 2-hour PPG (6.14 and 6.29 mmol/L), FPG (2.02 and 1.70 mmol/L), and patients with HbA1c <7.0% (52.6% and 51.0%) and ≤6.5% (34.2% and 30.9%), in the Rapilin and NovoRapid groups, respectively, with no significant safety or immunogenicity outcome differences.
Conclusions
Rapilin demonstrated non-inferior glycemic control, and matching safety and immunogenicity to NovoRapid in patients with type 2 diabetes mellitus also receiving metformin over 24 weeks.
Trial registration
ChiCTR20003129041
Transparency
Declaration of funding
This research did not receive any specific grants from funding agencies in the public, commercial, or not-for-profit sectors.
Declaration of financial/other relationships
Damei Wang is an employee of Gan & Lee Pharmaceuticals Co Ltd. Other authors declare no financial relationships. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
All authors contributed to the conception and design, analysis and interpretation of the data, and revising paper critically for intellectual content. Jun Yao and Xiaohui Guo also contributed to the drafting of the paper. All authors gave their final approval of the version to be published and agree to be accountable for all aspects of the work.
Acknowledgements
Authors would like to thank Dr. Michelle Mazuranic, Dr. Naveen Samuel, Dr. Jia Lu and Dr. Michael Wilson (Gan & Lee Pharmaceuticals USA Corp.), and Dr. Wei Chen (Gan & Lee Pharmaceuticals, China) for critical review, Editage (www.editage.cn) for English language editing, and Hannah Wedge and Hamidah Ahmed (integrated medhealth communication [IMC], London, UK) for editorial and writing support, funded by Gan & Lee Pharmaceuticals.
Data availability statement
The data that support the findings of this study are openly available at http://www.medresman.org.cn.
Notes
i Rapilin is a registered trademark of Gan & Lee Pharmaceuticals Co Ltd, Beijing, China.
ii NovoRapid is a registered trademark of Novo Nordisk, Bagsvaerd, Denmark.
iii Basalin is a registered trademark of Gan & Lee Pharmaceuticals Co Ltd, Beijing, China.
iv Abasaglar is a registered trademark of Eli Lilly and Boehringer Ingelheim,