Glucose Control with Oral Insulin Tablet Similar to Injection in Study
This article is part of MPR's coverage of the American Diabetes Association's 77th Scientific Sessions (ADA 2017), taking place in San Diego, CA. Our staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back regularly for more news from ADA 2017.
A long-acting oral insulin tablet was found to be as effective as insulin glargine injection in a study involving 50 patients with type 2 diabetes, according to a double-blind, double-dummy feasibility study presented at the American Diabetes Association 77th Scientific Sessions in San Diego, CA.
The tablet, OI388GT (Oral insulin 338 formulated into a GIPET I tablet), is a basal, acylated insulin analog with a half-life of ~70 hours. Study patients (average age 61) were insulin-naive and had A1C levels ranging from 7–10% while taking metformin alone or with other oral antidiabetics. They were randomized 1:1 to receive OI388GT or insulin glargine U100 once daily for 8 weeks.
Both oral and injectable insulin substantially improved fasting plasma glucose (primary endpoint), HbA1c, and fructosamine with no differences between groups.
Fasting plasma glucose in the OI338GT group fell from 175mg/dL at baseline to 129mg/dL by end of treatment. In the insulin glargine group, fasting plasma glucose fell from 164mg/dL at baseline to 121mg/dL by end of treatment (difference 5.2 95% CI: -8.8, 19.1; P=0.4567). Regarding A1c levels, there was a decrease from 8.1 at baseline to 7.3 after treatment in the OI338GT group. For the insulin glargine group, the average A1C dropped from 8.2 at baseline to 7.1 after treatment (difference 0.30, 95% CI: -0.03, 0.63; P=0.0774).
Treatment-emergent hypoglycemia occurred in 6 patients in the OI338GT group (7 incidents) and also in 6 patients in the insulin glargine group (11 incidents). No severe adverse events were reported in either group; minor adverse events were reported in 15 and 17 patients in the OI338GT and insulin glargine groups, respectively.
“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, and VP of global development at Novo Nordisk A/S.
Novo Nordisk has halted the development of OI338GT due to low bioavailability and concluded that investment required to produce on a large scale is not commercially viable. The Company is continuing to research improve technologies for the development of OI338GT.
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