BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in Subjects With Pre-Diabetes

NCT02358668 | Completed Phase 2 Results

• 1 other identifier: SG01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-centre, 16-week, randomized, double-blind, placebo-controlled, 3-treatment arm pilot study to evaluate the efficacy and safety of BTI320 in the treatment of high risk subjects with pre-diabetes. This is a pilot study aiming to test whether taking a medicine named BTI320 that slows down carbohydrate absorption in the gut, will lower blood sugar. The study aims to recruit 60 individuals in Hong Kong. To take part in the study, subjects must have pre-diabetes, that is, they have blood sugar levels that are above normal but not reaching diabetes range. The medicine BTI320 is currently licensed as a health supplement in Hong Kong and is known alternatively as SUGARDOWN®. The investigators are comparing the effectiveness of BTI320 against a dummy tablet. Both tablets look and taste identical and during the study, subjects will not know which of these tablets they are taking. There is a 4 in 5 chance of receiving active medication and 1 in 5 chance of receiving placebo. Subjects will be followed up closely every 2 to 4 weeks for a period of time up to 22 weeks. The study visits will take between 30 minutes to 3 hours, depending on additional checks that are required on a particular visit including oral glucose tolerance test and meal tolerance test. At visits involving meal tolerance test, subjects will be required to stay for approximately 3 hours. In addition, at Visit 2, Visit 4 and 3 days before Visit 7, a continuous glucose monitoring system device will be installed. Throughout the study period, subjects will return to the study center for check-ups including careful enquiry about whether they have developed any side-effects from taking the medication, physical examination, as well as blood tests.

Conditions

Pre-Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo

  From baseline to Week 4

Secondary Outcomes (41)

• Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System

  From baseline to Week 16

• Changes in Subjects Treated With Low Dose BTI320 and High Dose BTI320 Compared With Placebo in Mean Post-meal Maximum Glucose on Continuous Glucose Monitoring System

  From baseline to Week 16

• Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Amplitude of Glucose Excursion on Continuous Glucose Monitoring System

  From baseline to Week 16

• Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose on Continuous Glucose Monitoring System

  From baseline to Week 16

• Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve for Glucose Levels >180mg/dL on Continuous Glucose Monitoring System

  From baseline to Week 16

Other Outcomes (3)

• Changes in Serum Creatinine in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

  From baseline to Week 16

• Changes in Measures of Liver Function in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

  From baseline to Week 4, Week 8, Week 12, and Week 16

• Changes in Complete Blood Count in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

  From baseline to Week 4, Week 8, Week 12, and Week 16

Study Arms (3)

BTI320 4 grams

EXPERIMENTAL

three times daily, oral for 16 weeks

Drug: BTI320

BTI320 8 grams

EXPERIMENTAL

three times daily, oral for 16 weeks

Drug: BTI320

BTI320 matching placebo

PLACEBO COMPARATOR

2 tablets three times daily, oral for 16 weeks

Drug: BTI320 matching placebo

Interventions

BTI320 DRUG

BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.

Also known as: SUGARDOWN®

BTI320 4 grams; BTI320 8 grams

BTI320 matching placebo DRUG

Placebo

BTI320 matching placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects ≥ 18-70 years inclusive
• Chinese ethnicity
• High risk subject with pre-diabetes as defined by meeting at least 2 of the following criteria from (a), (b) and (c):
• FPG ≥ 5.6-6.9 mmol/l and/or 2-hour PG ≥ 7.8-11.0 mmol/l during 75 gram OGTT
• HbA1c ≥ 5.7-6.4%
• At least one of the following risk factors:-
• History of gestational diabetes
• Family history of diabetes in first degree relative
• components or more of the metabolic syndrome (triglyceride ≥ 1.7 mmol/L, blood pressure (BP) ≥ 130/80 mmHg, high density-lipoprotein (HDL) cholesterol \<1.3 mmol/L in women or \<1.1 in men and waist circumference ≥ 80 cm in women or ≥ 90 cm in men). Patients on anti-hypertensive agent for treatment of hypertension or lipid lowering drug for the treatment of hyperlipidaemia will respectively be considered to have one component of the metabolic syndrome.
• Subject is capable of giving informed consent prior to the initiation of any study related procedures
• A female subject of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate and effective contraception to avoid pregnancy during the study period and up to 30 days after the final visit.
• The subject is able and willing to consistently record food diary to facilitate CGMS evaluation.

You may not qualify if:

• Subject has received anti-diabetic agents within 6 weeks prior to screening visit.
• On dietary supplement known to affect glucose or galactose metabolism.
• History of acute cardiovascular disease including myocardial infarction, acute coronary syndrome or stroke which required hospitalization in the last 12 months.
• Significant renal impairment with estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2
• Known lactose or galactose intolerance.
• History of eating disorder.
• Pregnant or lactating female subjects.
• Subjects with gastrointestinal disease that may interfere with absorption of the investigational product.
• Subject has received any investigational product within 30 days of randomization visit.
• Reduced life expectancy or any condition considered by the investigator as unsuitable for enrolment.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Sugardown Company Limited: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

Related Publications (1)

• Luk AOY, Zee BCY, Chong M, Ozaki R, Rausch CW, Chan MHM, Ma RCW, Kong APS, Chow FCC, Chan JCN. A proof-of-concept study to evaluate the efficacy and safety of BTI320 on post-prandial hyperglycaemia in Chinese subjects with pre-diabetes. BMC Endocr Disord. 2018 Aug 31;18(1):59. doi: 10.1186/s12902-018-0288-5.

  PMID: 30170579 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

PAZ320

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr Andrea Luk
• Organization: The Chinese University of Hong Kong

andrealuk@cuhk.edu.hk

852-26324276

Study Officials

• Andrea OY Luk, MBBS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assocoiate Professor

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 9, 2015
• Study Start: March 30, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 19, 2016
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-03

Locations

HK (1)