Diabetes medicationPeter Sayer, Alison Bloomer, and Eve Batt report from the 77th annual Scientific Sessions of the American Diabetes Association (ADA).

Safe and effective oral insulin has been a long- sought after treatment option in diabetes research. As an alternative to routine insulin injections, an easy-to-take oral insulin tablet has the potential to increase patients’ medication compliance and may facilitate earlier initiation of insulin therapy.

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 7–10%, 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 80–126mg/dL, doses of both insulins were gradually increased once weekly on an individualised 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 (low blood glucose) 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).

“The results of our feasibility study show for the first time that it’s possible to develop, on a small- scale level, therapeutically meaningful insulin in an easy-to-take oral tablet,” said study co-author, Karsten Wassermann, project vice president of global development at Novo Nordisk A/S.

“Oral insulin has long been considered a highly desirable option in diabetes research, potentially freeing patients from continuous injections in favor of an easy-to-take tablet. While these data are highly encouraging, there is a need to optimize the tablet to further increase the insulin bioavailability.

"Within the scientific community there is an ongoing search for alternative ways to administer insulin so that we can enable diabetes patients to receive insulin without continuously breaking the skin barrier with a needle. The goal is to provide optimal coverage and ease insulin therapy for patients with diabetes, and now, we’re one step closer to achieving that vision.”