Efficacy and safety of domestic liraglutide injection in adults with type 2 diabetes mellitus: a multicenter, randomized controlled equivalence trial.

Objective To evaluate the efficacy and safety of the domestic liraglutide injection (RD12014) in patients with type 2 diabetes mellitus (T2DM) using the imported liraglutide injection (Victoza®) as a control. Methods A multicenter, randomized, open-label, parallel, positive-controlled phase III clinical trial was conducted. From August 20, 2020 to July 18, 2022, a total of 468 T2DM patients with poor glycemic control after using metformin hydrochloride were enrolled from 41 centers nationwide. They were then randomly assigned to the RD12014 group or Victoza® group in a 1:1 ratio for 29 weeks using a stratified block randomization method. Glycated hemoglobin A1c (HbA1c), fasting plasma glucose, 2-hour postprandial glucose, fasting lipid profile body weight, HbA1c compliance rate, the incidence of adverse events (including gastrointestinal reactions and hypoglycemic events) were compared between the two groups before and after treatment. The primary efficacy endpoint was the change from baseline in HbA1c after 29 weeks of treatment; the secondary efficacy endpoints were the change from baseline in fasting plasma glucose, 2-hour postprandial plasma glucose, fasting lipid profile, and body weight after 29 weeks of treatment, the proportion of subjects with HbA1c<7%, HbA1c≤6.5%, and the proportions of subjects with HbA1c<7%, HbA1c≤6.5% without hypoglycemic events after 29 weeks of treatment. The mixed effects model for repeated measures was used to evaluate quantitative efficacy endpoints, and the HbA1c compliance rate between groups was analyzed using logistic regression models; descriptive statistical analysis was used for safety evaluation. Results A total of 468 T2DM patients (RD12014 group: 233 cases, Victoza® group: 235 cases) were enrolled. After 29 weeks of treatment, the least-squares mean (95%CI) in the changes from baseline in HbA1c for the RD12014 group and the Victoza® group were -1.42% (-1.54%-1.29%) and -1.41% (-1.54%-1.29%), respectively. The least squares mean difference (95%CI) in the change from baseline between the two groups was -0.01% (-0.18%-0.17%), with the 95%CI within the equivalence margin of -0.4%-0.4%, indicating that the efficacy of RD12014 was similar to Victoza®. Changes from baseline in fasting blood glucose, 2-hour postprandial blood glucose, and body weight, and the rate of HbA1c compliance were similar in both groups (P>0.05). The incidence of adverse events [81.4% (188/231) vs. 80.0% (188/235), respectively] and gastrointestinal reactions [45.5% (105/231) vs. 39.1% (92/235)] were similar in the RD12014 group and the Victoza® group, while the incidence of hypoglycemic events in the RD12014 group [4.3% (10/231)] was slightly lower than those in the Victoza® group [8.9% (21/235)]. Conclusion Domestic liraglutide injection RD12014 is as effective and safe as Victoza® in the treatment of T2DM and has value in clinical use. [ABSTRACT FROM AUTHOR]