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

• Status: Completed
• Trial end date: 2016-02-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborator: Sugardown Company Limited
• Treatments: PAZ320

Criteria

Inclusion Criteria:

1. Adult subjects ≥ 18-70 years inclusive

2. Chinese ethnicity

3. High risk subject with pre-diabetes as defined by meeting at least 2 of the following criteria from (a), (b) and (c):

1. FPG ≥ 5.6-6.9 mmol/l and/or 2-hour PG ≥ 7.8-11.0 mmol/l during 75 gram OGTT

2. HbA1c ≥ 5.7-6.4%

3. At least one of the following risk factors:-

• 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.

4. Subject is capable of giving informed consent prior to the initiation of any study related procedures

5. 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.

6. The subject is able and willing to consistently record food diary to facilitate CGMS evaluation.

Exclusion Criteria:

1. Subject has received anti-diabetic agents within 6 weeks prior to screening visit.

2. On dietary supplement known to affect glucose or galactose metabolism.

3. History of acute cardiovascular disease including myocardial infarction, acute coronary syndrome or stroke which required hospitalization in the last 12 months.

4. Significant renal impairment with estimated glomerular filtration rate (eGFR) < 60ml/min/1.73m2

5. Known lactose or galactose intolerance.

6. History of eating disorder.

7. Pregnant or lactating female subjects.

8. Subjects with gastrointestinal disease that may interfere with absorption of the investigational product.

9. Subject has received any investigational product within 30 days of randomization visit.

10. Reduced life expectancy or any condition considered by the investigator as unsuitable for enrolment.