J Diabetes Metab Disord. 2025 Mar 20;24(1):86. doi: 10.1007/s40200-025-01602-y. eCollection 2025 Jun.
ABSTRACT
INTRODUCTION: Diabetes management often requires insulin therapy, yet adherence to daily injections can be challenging due to complexity, injection pain, and fear of hypoglycemia. Basal Insulin Fc (BIF) is a novel once-weekly insulin analog designed to simplify regimens, improve adherence, and enhance glycemic control. This meta-analysis evaluates the efficacy and safety of BIF compared to once-daily insulin degludec.
METHODS: A systematic search of PubMed, Google Scholar, EBSCO, ScienceDirect, and the Cochrane Library, along with ClinicalTrials.gov, was conducted up to November 2024 to identify RCTs comparing BIF with insulin degludec. The search employed MeSH terms like “type 1 diabetes mellitus,” “type 2 diabetes mellitus,” “once weekly basal insulin Fc,” and “insulin degludec.” Studies were screened in accordance with PRISMA guidelines, and data on glycemic outcomes, safety, and patient demographics were extracted. Statistical analysis included pooled mean differences (MD) and risk ratios (RR) with 95% confidence intervals (CIs) using random-effects models. Heterogeneity was assessed using the I2 statistic, and sensitivity analyses were conducted for cases of high heterogeneity. Subgroup and meta-regression analyses assessed moderators such as diabetes type, insulin status, follow-up duration, and heterogeneity.
RESULTS: Five RCTs with 2,562 participants (Type 1 and Type 2 diabetes) were included. BIF showed non-inferiority to degludec in HbA1c reduction (MD 0.03, p = 0.37) and percentage time in range (MD 0.56, p = 0.27). No significant differences were observed in self-monitored fasting blood glucose (MD 2.73, p = 0.40) or clinically significant hypoglycemia (RR 1.00, p = 0.95). However, BIF increased time spent below range (MD 0.30, p = 0.0004) and was associated with higher treatment-emergent adverse events (RR 1.12, p = 0.006). The subgroup analysis highlighted differences in hypoglycemia risks between Type 1 and Type 2 diabetes.
CONCLUSION: BIF offers comparable glycemic control to insulin degludec while reducing injection frequency, potentially enhancing adherence. However, increased hypoglycemia risks in certain subgroups and higher adverse event rates warrant further evaluation.
SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40200-025-01602-y.
PMID:40123989 | PMC:PMC11923323 | DOI:10.1007/s40200-025-01602-y
