Oral insulin tablet comparable to insulin glargine injection for glycemic control in patients with type 2 diabetes

By Liz Meszaros, MDLinx
Published June 26, 2017

Key Takeaways

A long-acting oral insulin tablet—OI338GT—is safe and as effective in increasing glycemic control as the common injected insulin glargine in patients with type 2 diabetes, according to researchers at the 77th Scientific Sessions of the American Diabetes Association.

Researchers assessed the efficacy and safety of OI338GT in comparison to injectable insulin glargine in 50 patients with type 2 diabetes who had never been treated with any type of insulin (average age: 61 years). A1C levels ranged from 7% to 10% in these patients when treated with metformin alone or in combination with other oral diabetes medications.

They randomized patients 1:1 to a once-daily tablet of OI338GT or an injection of insulin glargine (U100, IGlar) once daily for 8 weeks. To achieve fasting plasma glucose levels of 80 to 126 mg/dL, dosages for both insulin treatments were gradually increased weekly until no additional therapeutic benefit occurred.

Both the oral insulin tablet and injectable IGlar effected signfiicant improvements in blood glucose levels and other efficacy parameters. At 8 weeks, there were no significant differences between the two insulins.

Patients treated with OI338GT had average baseline A1Cs of 8.1, and ended the study with an average of 7.3. In the IGlar group, these corresponding values were 8.2 and 7.1, respectively.

Hypoglycemic episodes were limited, and similar in both groups, and no severe hypoglycemic episodes occurred. In 6 OI338GT patients and 6 IGlar patients, 7 and 11 incidents, respectively, of treatment-emergent hypoglycemia occurred.

The incidence of adverse events was similar, and there were no severe adverse events found in either group. In all, 68 adverse events occurred in 32 patients, broken out as 31 events in 15 OI338GT subjects, and 37 events in 17 IGlar patients.

"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, PhD, DSc, 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 easy-to-use insulin therapy for patients with diabetes, and now, we’re one step closer to achieving that vision," concluded Dr. Wassermann.

Currently, Novo Nordisk has halted further development of this particular oral insulin project due to low bioavailability and, hence, the required overall investments to produce OI338GT in quantities for wide public use have been assessed to not be commercially viable. The focus of ongoing research, however, has become improving technologies involved in the product’s development.

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