Sugardown® Research & Trials

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Protocol Title: A Study to Evaluate the Effect of BTI320 (SUGARDOWN® ) on Post- Prandial Hyperglycemia in High Risk Chinese Subjects with Pre-Diabetes

BTI320 significantly reduced postprandial hyperglycemia and glycemic variability, as measured by CGMS in subjects at high risk for diabetes. Treatment with low doses of BTI320 significantly attenuated post-prandial rise in blood glucose at 1, 2 and 3 hours post-meal and reduced body weight. Given the ease of administration and high levels of tolerance, BTI320 has the potential to be used as an adjunct to lifestyle modification for diabetes prevention. Future research is required to test the feasibility and effectiveness of BTI320 as part of a larger program for diabetes prevention.

A proof-of-concept study to evaluate the efficacy and safety of BTI320 on postprandial hyperglycaemia in Chinese subjects with pre-diabetes.

In this proof-of-concept study of subjects with prediabetes, low dose BTI320 (4 g three times daily) did not reduce fructosamine levels at 4 weeks as specified in the primary endpoint but the attenuated post-prandial rise in blood glucose based on CGM with modest weight loss. Future research
will be required to test and confirm the glycaemic and weight effects of BTI320 in a larger sample.

Phase 1 Study of the Pharmacology of BTI320 Before High-Glycemic Meals

BTI320 attenuated postprandial rise in blood glucose level as well as having a positive effect on lipid profile. The association between corresponding glycemic and insulin excursions on ingestion of the
investigative compound was found to be dose-dependent in obese yet otherwise healthy individuals. Because of its ease of administration and high levels of tolerance, BTI320 has the potential to be used as an adjunct
to lifestyle modification to prevent glucose excursion. Further studies are ongoing to assess the influence of BTI320 on glucose excursions in type 2 diabetics and ensuing long-term diabetic complications.

A dose-ranging study of BTI320 in type 2 diabetic patients

Data from this proof of concept study comparing two doses (4 and 8 g) of BTI320 demonstrated evidence of 4 g BTI320 in reducing glucose excursions compared with the 8 g BTI320 and placebo arms per subject. Whereas these data support other published studies of BTI320 limiting the magnitude of glucose excursion, variables such as rate of glucose absorption, age of the patient, and amount of carbohydrates in each meal, amongst others, require an expanded population in a Phase 3 trial to confirm these findings.