BTI320 is a proprietary fractionated mannan polysaccharide being studied for attenuation of postprandial glucose excursion. The apparent blood glucose-lowering effect of this compound is effective in lowering postprandial hyperinsulinemia, participating in the metabolic regulation of other lipid molecules; the consequence of this activity is yet to be validated with BTI320 with respect to the risk of cardiovascular disease. The primary objective of the study was to determine the postprandial glucose and insulin responses to 3 test meals containing rice alone or consumed with BTI320 (study A) or 3 test meals (Sprite ) alone or consumed with BTI320 (study B). Twenty overweight but otherwise healthy volunteers, 4 female and 6 male (mean age 29 years, BMI 27-28 kg/m ) in study A and 6 female and 4 male (mean age 32 years, BMI 25-32 kg/m ) in study B participated in the BTI320 evaluations. Standardized postprandial response methodology was utilized. In study A the addition of 6- and 12-g BTI320 tablets reduced postprandial glucose responses to white rice by 19% and 32% and reduced postprandial insulin responses by 16% and 24%, respectively (P ≤ .05). In study B 2.6 and 5.2 g BTI320 reduced the glycemic index by 10% and 14%, respectively, and led to 14% and 18% decreases in the insulinemic index of the soft drink (P ≤ .05). These 2 studies demonstrated that the consumption of BTI320 before carbohydrate food or sugary beverage significantly reduced postprandial glucose levels and insulin responses to that meal or beverage in a dose-dependent manner.

Background/objectives: Current practice is to treat diabetics with oral hypoglycemics, insulin, or a combination of both; these systemic interventions are not without risk. The reduction in glucose excursion is a new therapeutic paradigm with non-systemic interventions which has been suggested to delay diabetic-associated complications. BTI320, derived from galactomannan, is a non-systemic drug to attenuate postprandial glucose excursion by blocking carbohydrate hydrolyzing enzymes within the gastrointestinal tract. Earlier studies of BTI320 have shown decreased glucose excursions with relatively few adverse effects.Subjects/methods: This double-blind, placebo-controlled, 3-period crossover, outpatient study evaluated two different doses of BTI320, 4 g and 8 g three times daily before meals, for 7 days in 23 adults with Type 2 diabetes (mean age 54 years, BMI 31.4 kg/m 2 ). The primary endpoint of the response of postprandial glucose excursion was measured by the area under the curve from 0 to 4 hours (PPG-AUC0-4) following a high carbohydrate meal on the final day of dosing in each crossover arm. Results:The mean (± SD) PPG-AUC0-4 after 7 days of dosing placebo, 4 g, and 8 g BTI320 were 179.09 ± 157.271, 146.61 ± 98.604, and 179.09 ± 157.27 mmol/L*min, respectively, in the intent-to-treat population, demonstrating appreciable effects of 4 g BTI-320 compared with placebo. Similar trends were found in the PPG peak glucose levels and time to peak glucose concentrations. Consistent with other studies, the mean glucose serum concentrations at 2 hours following 4 g BTI320 (7.57 ± 1.519 mmol/L) were markedly lower than those following placebo and 8 g BTI320 (7.63 ± 1.826 and 7.68 ± 1.711 mg/dL, respectively). Conclusion: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.

Background/Purpose: Treatment of Type 2 diabetes (T2D) remains an unmet need, particularly a medication with low toxicity. BTI320 (SugarDown®) is fractionated galactomannan with inhibitory activity on carbohydratehydrolyzing enzymes. The primary objective of this study was to investigate the efficacy and safety of BTI320 on glycemic control in T2D. Subjects/Methods: This was a double-blind, placebo-controlled, multi-center study in 60 T2D adults. Subjects ingested 4 g BTI320 or placebo 10 minutes before meals 3 times daily for 12 weeks. The primary endpoint was the change from Baseline to Week 12 in 2-hr post-prandial glucose (PPG) AUC between groups. Results/Conclusion: A consistent trend was observed in favor of BTI320 vs. placebo in change from Baseline at Week 12 in 2-hr PPG AUC (-795.00 vs. -228.75 mg/dL*min), HbA1c (-0.7% vs. +1.1%), lipids, weight/BMI, and blood pressure. At Week 12, BTI320 had more subjects with stable glucose levels (84.6% vs. 79.2%). According to CGM, the BTI320 group had more subjects with stable glucose levels (84.6 vs. 79.2%) and BTI320 subjects experienced relative hypoglycemia for shorter duration than placebo consistently across all visits. No differences were observed in AE profiles between groups. BTI320 was proven to be efficacious and safe in T2D. This study is registered at ClinicalTrials.gov (NCT03655535).