SAN DIEGO — Adults with type 2 diabetes assigned to once-daily oral insulin achieve similar HbA1c and fasting plasma glucose levels compared with those assigned to once-daily subcutaneous insulin, according to a presenter here.
“When we look at the opportunity for an easy-to-take pill with insulin, the most apparent thing that comes to mind is that there is no need for injection,” Karsten Wassermann, PhD, DSc, project vice president of global development at Novo Nordisk, said during a press conference. “But beyond that, it is perceived that oral administration of insulin leads to a direct effect on the liver that potentially would lower the risk of hypoglycemia.”
Wassermann and colleagues evaluated 50 insulin-naive adults (mean age, 60 years) with type 2 diabetes (HbA1c, 7%-10%; BMI, 25-40 kg/m2) who were randomly assigned to once-daily oral insulin 338 (GIPET I, Novo Nordisk) plus subcutaneous placebo (n = 25) or once-daily subcutaneous insulin glargine plus oral placebo (n = 25) for 8 weeks to compare glycemic control and safety between the two.
Insulin doses were gradually increased once per week until no additional therapeutic benefit was seen and participants achieved a fasting plasma glucose in the target range of 80 mg/dL to 126 mg/dL.
After 8 weeks of treatment, mean fasting plasma glucose levels were similar between the oral insulin 338 group (129 mg/dL) and insulin glargine group (121 mg/dL). Further, mean HbA1c values were also similar after 8 weeks in the oral insulin 338 group (7.3%) and insulin glargine group (7.1%).
“We have demonstrated that oral basal insulin safely can improve glycemic control in patients insufficiently controlled with oral antidiabetic drugs,” Wassermann said. “It appears possible to develop therapeutically meaningful basal insulin in a table formulation at least on a small scale, and this is an achievement which is a world premier since the discovery of insulin in 1921. There is belief that this will be a very easy way to initiate insulin treatment in subjects with type 2 diabetes, and through this it may also facilitate an increased compliance leading to better metabolic control.” – by Amber Cox
Plum-Mörschel L, et al. 380-OR. Presented at: American Diabetes Association 77th Scientific Sessions; June 9-13, 2017; San Diego.
Disclosures: Wassermann reports being an employee and shareholder of Novo Nordisk.