BTI320 (SUGARDOWN®) on Post-Prandial Hyperglycaemia in Subjects With Pre-Diabetes
Condition: Pre-Diabetes
MeSH terms: Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
Intervention: BTI320; BTI320 matching placebo
Intervention description: 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.; Placebo
Intervention MeSH terms: PAZ320
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility 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.