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news.The US Food and Drug Administration (FDA) has accepted Boston Therapeutics' investigational new drug (IND) application to start a clinical trial of BTI-320 to treat type 2 diabetes and weight management.
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BTI-320 is a non-systemic chewable complex carbohydrate-based compound developed to reduce post-meal elevation of blood glucose.
The trial’s primary endpoints are the mean change in Hemoglobin A1c (or HbA1c) and weight loss.
The Joslin Diabetes Center in Boston will be the lead clinic in the trial, which is scheduled to be initiated in the first quarter of 2015.
Boston Therapeutics chief executive officer David Platt said: "Earlier this year, we completed a US-based Phase IIb study of BTI-320 in patients with Type 2 diabetes and reported positive topline results.
"The results of our studies to date provided us with information on different patient populations and doses that have allowed us to design a protocol for this trial using mean change in HbA1c as the primary endpoint, which is the standard for measuring efficacy in currently available diabetes therapies."
The randomized, placebo-controlled, double-blind, international multicenter trial will have two treatment arms and will evaluate the effect of BTI-320 in addition to current treatment with metformin, Dipeptidyl peptidase-4 inhibitors (DPP-4), sulfonylureas and/or long-acting insulin analog on glucose control in patients with type 2 diabetes.
About 360 subjects will be enrolled in the trial, which will be conducted at number of international centers located in the US, Europe, Asia and Australia.