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New study

Drug that mimics bypass assessed for T2DM treatment

Study is to help determine if administration of L-glutamine or sodium butyrate suppositories results in a decrease in blood glucose levels

BioKier has initiated a randomised, double-blind, placebo-controlled, parallel dose group study to evaluate changes in fasting glucose after a four-week treatment period with L-glutamine or sodium butyrate administered by rectal suppository. Led by Dr Adrian Vella, Mayo Clinic; Rochester, MN, the study is being conducted to provide data to support future clinical investigations of an oral drug (capsule) for the treatment of T2DM.

The purpose of this study is to help determine if administration of L-glutamine or sodium butyrate suppositories results in a decrease in blood glucose levels and evaluate whether the safety and effectiveness of an investigational drug that is being developed for the treatment of type 2 diabetes.

Study subjects will be asked to test their blood glucose, maintain a daily record of glucose values, eating and bowel habits and record of self-administered treatment. The treatments are given by suppository three times per day for a total of 4 weeks.

The study will take about ten weeks to complete this research study, which includes a four-week screening period, four week treatment period and a follow up phone call two weeks after the final study visit. During this time, subjects will make six study visits to the Clinical Research Unit.

The company is developing a proprietary oral treatment for diabetes based on understanding the mechanism of the anti-diabetic effects of gastric bypass surgery. 

Gastric bypass surgery, independent of its weight loss effect, substantially improves or even resolves diabetes within days in 80-90% of obese type 2 diabetes patients. This surgery is equally effective in non-obese diabetes patients.

There is strong evidence that the mechanism of this effect is expedited delivery to the lower gut of certain nutrients which are natural secretagogues for glucoregulatory gut hormones.

BioKier has devised a proprietary method to potentially mimic the effects of surgery and to improve or resolve diabetes, but without the physical trauma and cost of bariatric surgery. It is expected to be suitable for both obese or non-obese diabetes patients.

The treatment acts by stimulating the L-cells in the lower gut with an orally delivered therapeutic and thus correcting the deficiency in secretion of endogenous GLP-1 and other gut hormones, such as PYY, GLP-2 and oxyntomodulin. This treatment will potentially also have beneficial effects in metabolic syndrome, cardiovascular disease, and obesity.

The company believes its novel therapeutic will be an oral, once-a-day pill and will address a putative causative factor of diabetes rather than just the symptoms.

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