A long–acting, oral insulin tablet has been found to safely improve glycemic control as effectively as the common, injected insulin glargine in people with Type 2 diabetes, according to the study, “Efficacy and Safety of Oral Basal Insulin: Eight–Week Feasibility Study in People with Type 2 Diabetes (T2DM),” presented at the American Diabetes Association’s 77th Scientific Sessions.

The study evaluated the effectiveness and safety of OI338GT, an oral insulin tablet, by comparing it to injectable insulin glargine. The study included 50 patients with type 2 diabetes, average age of 61 years and who had never taken any type of insulin. The patients had A1C levels ranging from 7 to 10 percent, while on metformin alone or in combination with other oral diabetes medications. The patients were randomized 1:1 to receive a once daily treatment tablet of OI338GT, or an injection of insulin, glargine U100 (IGlar), once daily for a period of eight weeks. The trial was fashioned as a “double–blind, double–dummy” study, meaning that all patients received one injection and one tablet a day, only one of which contained insulin. To enable participants to achieve a fasting plasma glucose in the target range of 80–126 mg/dL doses of both insulins were gradually increased once weekly on an individualized basis until no additional therapeutic benefit was seen.

The results showed that both the oral insulin tablet and injectable insulin glargine substantially improved blood glucose levels and other efficacy parameters, with no significant differences between the two insulins at eight weeks. Patients’ A1C levels at baseline were compared to their levels at the end of treatment, at eight weeks. The patients in the OI338GT group had an average baseline A1C of 8.1, and an average ending A1C of 7.3. Patients in the IGlar group had an average baseline A1C of 8.2, and an average ending A1C of 7.1.

The number of episodes of hypoglycemia was limited and similar in both treatment groups, and no severe hypoglycemia occurred. There were seven incidents of treatment–emergent hypoglycemia in six patients in the OI338GT group, and 11 incidents of treatment–emergent hypoglycemia in six patients in the IGlar group. The rate and type of adverse events was similar. No severe adverse events were observed in either treatment group. A total of 68 adverse events were reported in 32 patients (31 adverse events by 15 subjects treated with OI338GT, and 37 adverse events by 17 patients treated with IGlar).

Further development of this particular oral insulin project has been discontinued by Novo Nordisk because the bioavailability is low and, hence, the required overall investments to produce the OI338GT in quantities for wide public use have been assessed to not be commercially viable. Improvement of technologies involved in the product’s development is the focus of ongoing research.