Pre-DiabetesPhase 2NCT02358668
BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in Subjects With Pre-Diabetes
A Phase 2 study testing BTI320 in people with Pre-Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pre-Diabetes
- What is being tested?
- BTI320
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Mar 2015to 19 Feb 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:-
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- History of gestational diabetes
- Family history of diabetes in first degree relative
- 2 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in High Risk Chinese Subjects With Pre-Diabetes
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.
Read more
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.
Read the detailed description
In a recent national survey, 11% of adults in China have diabetes and 50% have pre-diabetes defined by fasting plasma glucose (FPG) 5.6-6.9 mmol/l and/or 2-hour post glucose (PG) 7.8-11.0 mmol/L using 75 gram oral glucose tolerance test (75g OGTT) and/or glycated haemoglobin (HbA1c) 5.7-6.4%. Depending on the presence of other risk factors, the annual conversion rate of pre-diabetes averages 3-10% with pre-diabetes associated with 1.5-2.0 fold increased risk for cardiovascular disease. Once diabetes is established, life expectancy is reduced by 6 years if not diagnosed, treated or controlled, especially in young-to-middle aged subjects who will face long disease duration of diabetes.
In the Hong Kong Diabetes Registry, depending on control of glucose and other risk factors, 3-10% of Chinese subjects with diabetes may die or develop a major event every year including heart disease, stroke, kidney failure and /or all-site cancer.
Besides glycaemic control as defined by HbA1c, post prandial hyperglycaemia and glycaemic variability have also been shown to predict cardiovascular and renal events in both pre-diabetic and diabetic patient. Genetic variants discovered in large-scale epidemiological studies including those from China and Hong Kong have been found to be associated with beta cell dysfunction which can be further exacerbated by glucotoxicity and lipotoxicity, often due to co-existing obesity giving rise to early onset diabetes. Several studies including those from Asian populations indicated that subjects with pre-diabetes exhibit reduced early phase insulin secretion resulting in postprandial hyperglycaemia which can impose metabolic stress on the beta cells leading to eventual beta cell failure.
BTI320, also known as SUGARDOWN®, is derived from galactomanan which acts by blocking the key carbohydrate hydrolyzing enzymes including amylase, maltose, lactose and sucrose in the gastrointestinal tract. It also acts to bind to ingested polysaccharides and slow their absorption with each meal thereby reducing post prandial glucose excursion. The mechanism of action for BTI320 is similar to Acarbose®, an alpha glucosidase inhibitor, which has been shown to improve glycaemic control and has been approved for prevention of diabetes in China.
24-hour continuous glucose monitoring system (CGMS) measures mean blood glucose (MBG), mean area under the curve for blood glucose above 10mmol/l (180mg/dl) (AUC-180), mean postprandial maximum glucose (MPMG), mean amplitude of glucose excursion (MAGE) over 72 hours. These parameters correlate well with plasma fructosamine (FA) alternatively known as glycated albumin, which reflects short-term glycaemic control during the preceding 2 weeks.
- Conditions
- Pre-Diabetes
- Being tested
- BTI320, BTI320 matching placebo
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTI320Drug
Also called SUGARDOWN®
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.
BTI320 matching placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BTI320 4 grams | Experimental | three times daily, oral for 16 weeks Receives: Drug: BTI320 |
| BTI320 8 grams | Experimental | three times daily, oral for 16 weeks Receives: Drug: BTI320 |
| BTI320 matching placebo | Placebo comparator | 2 tablets three times daily, oral for 16 weeks Receives: Drug: BTI320 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
Measured: 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
Changes in 3-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system from baseline to Week 16.
Note that this is not a pharmacokinetic study and this is not pharmacokinetic data as we are not measuring drug levels. Here we are examining glucose levels after meals as one of the anticipated glycemic outcomes of using glucose-lowering therapy (BTI320 in this case). With data-analysis based on continuous glucose monitoring, it is conventional to present post-prandial (i.e. post-meal) glucose incremental area under curve at up to 3 hours. It is not meaningful to look at post-meal glucose changes at more than 3 hours after meal for the obvious reason that subject might have taken another meal by then.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Area under curve for glucose levels >180 mg/dL over 72 hours
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System
Measured: From baseline to Week 16
Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
Measured: From baseline to Week 16
Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Glucose During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Changes in area under curve of glucose from 0 minute to 120 minutes from baseline to Week 16
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Insulin During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Changes in area under curve of insulin from 0 minute to 120 minutes from baseline to Week 16
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of C-peptide During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Changes in area under curve of C-peptide from 0 minute to 120 minutes from baseline to Week 16
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Glucagon-like Peptide 1 During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Changes in area under curve of glucagon-like peptide-1 from 0 minute to 120 minutes from baseline to Week 16
Measured: From baseline to Week 16
Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group
Proportion of subjects with impaired fasting glucose, impaired glucose tolerance, both impaired fasting glucose and impaired glucose tolerance, HbA1c 5.7-6.4%, or type 2 diabetes at 30 days post-treatment
Measured: From baseline to 30 days post-treatment
Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Changes in systolic blood pressures from baseline to Week 16
Measured: From baseline to Week 16
Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Measured: From baseline to Week 16
Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Measured: From baseline to Week 16
Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Changes in total cholesterol from baseline to Week 16.
Measured: From baseline to Week 16
Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo
Measured: From baseline to Week 16
Changes in Urate in Subjects Treated With High Dose and Lose Dose BTI320 Compared to Placebo
Measured: From baseline to Week 16
Changes in Quality of Life Measures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Changes in WHOQOL-BREF physical health domain score from baseline to Week 16. This is a sub-scale of the WHOQOL-BREF. Possible scores range from minimal of 4 to maximum of 20. Higher score indicate better physical health domain.
Measured: From baseline to Week 16
Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Changes to question of "how full do you feel" in the Appetite Questionnaire adopted from Hill and Blundell from baseline and Week 16. Scale score ranges from minimum of 0 to maximum of 10. 10 being the most full and 0 being the least full.
Measured: From baseline to Week 16
Changes in Measures of Nutritional Intake in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Changes in daily calories intake from baseline to Week 16
Measured: From baseline to Week 16
Changes in Measures of Exercise in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Changes in the number of days per week that the subject spent walking for at least 10 minutes from baseline to Week 16
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 1 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 2 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 3 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 1 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 2 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 3 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Post-prandial Maximum Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Maximum Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
Measured: From baseline to Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start30 Mar 2015
- Primary completionFeb 2016
- Study completion19 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre-DiabetesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Sugardown Company Limited
- Responsible party
- Principal investigator, Andrea On Yan Luk, Chinese University of Hong Kong
- Investigators
- Andrea OY Luk, MBBS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358668
- Sponsor's protocol ID
- SG01
- Status last verified
- Mar 2017
- First submitted
- 30 Jan 2015
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 30170579
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in High Risk Chinese Subjects With Pre-Diabetes
- ClinicalTrials.gov ID
- NCT02358668
- Acronym / sponsor ID
- SG01
- Conditions
- Pre-Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Sugardown Company Limited
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- 19 Feb 2016 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In a recent national survey, 11% of adults in China have diabetes and 50% have pre-diabetes defined by fasting plasma glucose (FPG) 5.6-6.9 mmol/l and/or 2-hour post glucose (PG) 7.8-11.0 mmol/L using 75 gram oral glucose tolerance test (75g OGTT) and/or glycated haemoglobin (HbA1c) 5.7-6.4%. Depending on the presence of other risk factors, the annual conversion rate of pre-diabetes averages 3-10% with pre-diabetes associated with 1.5-2.0 fold increased risk for cardiovascular disease. Once diabetes is established, life expectancy is reduced by 6 years if not diagnosed, treated or controlled, especially in young-to-middle aged subjects who will face long disease duration of diabetes.
In the Hong Kong Diabetes Registry, depending on control of glucose and other risk factors, 3-10% of Chinese subjects with diabetes may die or develop a major event every year including heart disease, stroke, kidney failure and /or all-site cancer.
Besides glycaemic control as defined by HbA1c, post prandial hyperglycaemia and glycaemic variability have also been shown to predict cardiovascular and renal events in both pre-diabetic and diabetic patient. Genetic variants discovered in large-scale epidemiological studies including those from China and Hong Kong have been found to be associated with beta cell dysfunction which can be further exacerbated by glucotoxicity and lipotoxicity, often due to co-existing obesity giving rise to early onset diabetes. Several studies including those from Asian populations indicated that subjects with pre-diabetes exhibit reduced early phase insulin secretion resulting in postprandial hyperglycaemia which can impose metabolic stress on the beta cells leading to eventual beta cell failure.
BTI320, also known as SUGARDOWN®, is derived from galactomanan which acts by blocking the key carbohydrate hydrolyzing enzymes including amylase, maltose, lactose and sucrose in the gastrointestinal tract. It also acts to bind to ingested polysaccharides and slow their absorption with each meal thereby reducing post prandial glucose excursion. The mechanism of action for BTI320 is similar to Acarbose®, an alpha glucosidase inhibitor, which has been shown to improve glycaemic control and has been approved for prevention of diabetes in China.
24-hour continuous glucose monitoring system (CGMS) measures mean blood glucose (MBG), mean area under the curve for blood glucose above 10mmol/l (180mg/dl) (AUC-180), mean postprandial maximum glucose (MPMG), mean amplitude of glucose excursion (MAGE) over 72 hours. These parameters correlate well with plasma fructosamine (FA) alternatively known as glycated albumin, which reflects short-term glycaemic control during the preceding 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BTI320 4 grams | Experimental | Drug: BTI320three times daily, oral for 16 weeks |
| BTI320 8 grams | Experimental | Drug: BTI320three times daily, oral for 16 weeks |
| BTI320 matching placebo | Placebo comparator | Drug: BTI320 matching placebo2 tablets three times daily, oral for 16 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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):
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTI320Also: SUGARDOWN®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. | Drug | BTI320 4 grams, BTI320 8 grams |
| BTI320 matching placeboPlacebo | Drug | BTI320 matching placebo |
Primary outcome
Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
Time frame: From baseline to Week 4
41 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System
Time frame: From baseline to Week 16
Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
Time frame: From baseline to Week 16
Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Glucose During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of Insulin During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Area Under Curve of C-peptide During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Glucagon-like Peptide 1 During Standard Meal Tolerance Test From 0 Minute to 120 Minutes
Time frame: From baseline to Week 16
Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group
Time frame: From baseline to 30 days post-treatment
Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo
Time frame: From baseline to Week 16
Changes in Urate in Subjects Treated With High Dose and Lose Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Quality of Life Measures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Measures of Nutritional Intake in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Measures of Exercise in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 1 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 2 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean 3 Hour Post-prandial Glucose Incremental Area Under Curve on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 1 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 2 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in 3 Hour Post-prandial Mean Blood Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Post-prandial Maximum Glucose on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Post-prandial Maximum Glucose During 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose During 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Blood Glucose Over 24 Hours on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 1 Hour Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 2 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation of Blood Glucose Over 3 Hours Post-prandial on Continuous Glucose Monitoring System Repeated Measures Analysis
Time frame: From baseline to Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30170579Luk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea OY Luk, MBBS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTI320 in people with Pre-Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo (time frame: From baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.