Both oral basal insulin (I338) and subcutaneous insulin glargine (IGlar) have been used to manage glucose levels in patients with type-2 diabetes. The study aims to evaluate the efficacy and safety of I338 and IGlar in patients with type-2 diabetes.
This is a randomized, double-blind, active-controlled, double-dummy, phase-2, parallel trial conducted in two research institutes in Germany. The study included a total of 50 insulin-naive adult patients with type 2 diabetes. The participants were randomly assigned in a 1:1 ratio to receive once-daily I338 with a subcutaneous placebo or once-daily IGlar with an oral placebo. The primary outcome of the study was the difference in fasting plasma glucose (FPG) concentration at 8 weeks.
Out of 50 patients, 25 each were assigned to the I338 and IGlar groups. The mean FPG concentration at baseline in the I338 group was 9.7, and in the IGlar group, it was 9.1. Both the treatments were well-tolerated by the patients, and adverse events were reported in 15 (60%) of I338 patients and 17 (68%) of the IGlar patients.
The research concluded that both I338 and IGlar are equally effective in improving glycemic control in insulin-naive patients without a significant risk of adverse events or treatment intolerance.