Positive results have been reported from a phase 2b study of an investigational oral insulin capsule (ORMD-0801) in patients with type-2 diabetes (T2D). The study’s primary objective––a significant reduction of weighted mean night-time glucose––was successfully achieved.
The four-week, double-blind, randomized trial was initiated in June 2015 and was conducted at 33 clinical sites in the United States. The study was designed to assess the safety and efficacy of multiple oral bedtime doses of ORMD-0801 in adult patients with T2D who were inadequately controlled with diet and metformin. The study consisted of three treatment arms: ORMD-0801 16 mg, ORMD-0801 24 mg, and placebo. A total of 180 patients were dosed before bed-time, and their night-time glucose levels (six hours post-dose) were continuously monitored.
The investigators observed a statistically significant 6.47% decrease in pooled night-time glucose between the active treatments and placebo (P = 0.0268). In addition, the study demonstrated no drug-related serious adverse events.
These findings must be replicated in a larger phase 3 study before ORMD-0801can be submitted for FDA approval. Nevertheless, analysts view the positive study results as a major milestone.
According to the product’s developer (Oramed Pharmaceuticals), orally administered insulin is expected to enhance patient compliance. More important, intestinally absorbed oral insulin mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream. Injected insulin, on the other hand, circulates throughout the body before it reaches the liver, and some doctors believe that high levels of circulating insulin may increase health risks. ORMD-0801capsules consist of a protective coating and a high-enough dose of insulin so that most of the capsule can be destroyed in the digestive tract and still deliver a clinically beneficial amount of hormone.
Although insulin is typically associated with type-1 diabetes, many patients with T2D eventually progress to the point where they require insulin therapy. T2D accounts for more than 90% of the nearly 400 million people with diabetes worldwide.