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

Launched by CHINESE UNIVERSITY OF HONG KONG · Feb 3, 2015

Keywords

ClinConnect Summary

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 controlle...

Gender

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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.