Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
Last week, we reported on findings from a study published in Diabetes Therapeutics that compared the efficacy and safety of a biosimilar liraglutide (Meltitide®) to the branded reference product (Victoza®) in patients with type 2 diabetes (T2D).
Researchers recruited adults aged between 18 and 80 years with inadequately controlled T2D and HbA1c levels 7–10.5% on 2 or more oral glucose-lowering medications with stable doses for 3 months or longer; baseline body mass index range was 20-45 kg/m2. Eligible participants were randomly assigned in a 1:1 ratio to receive daily 1.8 mg biosimilar liraglutide or liraglutide for 26 weeks. The primary outcome of interest was noninferiority of the biosimilar to the reference liraglutide with a prespecified margin of 0.4%.
The secondary outcomes were proportion of participants who reached HbA1c targets (HbA1c <7%; HbA1c ≤6.5%) and additional measures of efficacy comprised of changes in body weight, fasting plasma glucose, blood pressure, pulse rate, lipid profile, and estimated glomerular filtration rate from baseline to week 26. Researchers also assessed immunogenicity and adverse outcomes between the 2 groups.
The final cohort numbered 300, with 150 individuals assigned to each study arm. A total of 235 patients were included in the per-protocol (PP) group, 112 receiving biosimilar liraglutide and 123 receiving liraglutide.
The mean changes in HbA1c from baseline to week 26 were similar between groups, –1.76% in the biosimilar liraglutide group and –1.59% in the liraglutide group (difference, –0.18; 95% CI, –0.50 to 0.15; P = .288). The team also reported that the upper limit of the one-sided 95% CI for the mean difference between the 2 study arms was lower than the predefined noninferiority margin (0.4%), confirming noninferiority of the biosimilar to the reference product in lowering HbA1c. Findings were consistent between the PP and intention-to-treat populations.
Secondary outcomes were analyzed among 112 patients in the biosimilar liraglutide and 125 patients in the reference liraglutide groups. Investigators identified no statistically significant differences between the 2 study arms in the proportion of patients achieving HbA1c <7% (P = .210), the range of other efficacy parameters (P > .05), or reported adverse events (P = .916).
Overall, 126 (83.44%) patients in the biosimilar liraglutide group and 125 (83.89%) patients in the liraglutide group experienced ≥1 adverse event, with gastrointestinal disorders most frequent and most considered mild or moderate.
"In this 26-week study, Melitide® was noninferior to Victoza® in terms of glycemic control. Moreover, both products were comparable in terms of weight reduction effect and safety profile."