Dataset Information

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

ABSTRACT:

Background

Galactomannan(s) are plant-derived fiber shown to reduce post-prandial blood glucose by delaying intestinal absorption of carbohydrates and slowing down gastric emptying. We examined glucose-lowering effects of BTI320, a propriety fractionated mannan(s) administered as a chewable tablet before meal in a proof-of-concept study in Chinese subjects with prediabetes.

Methods

Sixty Chinese adults aged 18-70 years with either impaired fasting glucose, impaired glucose tolerance, or glycated haemoglobin 5.7-6.4% (39-46 mmol/mol), were randomly assigned in 2:2:1 ratio to either BTI320 8 g (high dose), BTI320 4 g (low dose) or matching-placebo three times daily before meal for 16 weeks. The primary endpoint was change in fructosamine in subjects treated with BTI320 compared with placebo from baseline to week 4. Indices of glycaemic variability based on continuous glucose monitoring (CGM) and standard meal tolerance test were explored in secondary analyses.

Results

Of 60 subjects randomized, 3 subjects discontinued study treatment prematurely. In intention-to-treat analysis, no significant differences in change in serum fructosamine between low or high dose BTI320 and placebo were observed. Using random effect models, adjusted for variability by meals, treatment with low dose BTI320 was associated with reduction in 1-h (p < 0.01), 2-h (p = 0.01) and 3-h (p = 0.02) post-prandial incremental glucose area-under-curve and post-meal maximum glucose (p = 0.03) compared with placebo. Subjects receiving low dose BTI320 had greater body weight reduction than placebo group.

Conclusions

BTI320 did not change fructosamine levels compared with placebo. BTI320 reduced glycaemic variability based on CGM indices.

Trial registration

The study was registered at www.clinicaltrials.gov , reference number NCT02358668 (9 February 2015).

SUBMITTER: Luk AOY

PROVIDER: S-EPMC6119318 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Publications

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

Luk Andrea O Y AOY Zee Benny C Y BCY Chong Marc M Ozaki Risa R Rausch Carl W CW Chan Michael H M MHM Ma Ronald C W RCW Kong Alice P S APS Chow Francis C C FCC Chan Juliana C N JCN

BMC endocrine disorders 20180831 1

<h4>Background</h4>Galactomannan(s) are plant-derived fiber shown to reduce post-prandial blood glucose by delaying intestinal absorption of carbohydrates and slowing down gastric emptying. We examined glucose-lowering effects of BTI320, a propriety fractionated mannan(s) administered as a chewable tablet before meal in a proof-of-concept study in Chinese subjects with prediabetes.<h4>Methods</h4>Sixty Chinese adults aged 18-70 years with either impaired fasting glucose, impaired glucose toleran ...[more]

PMID: 30170579

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Dataset Information

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

Background

Methods

Results

Conclusions

Trial registration

Publications

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

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