BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in Subjects With Pre-Diabetes
Status:
Completed
Trial end date:
2016-02-19
Target enrollment:
Participant gender:
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.