Review by Chinese Medicine practitioner only

JinQi JiangTang Fang (Rhizoma Coptidis, Radix Astragali and Flos Lonicerae)

JQJT plus extra low dose Ophiopogonis Radix

Prediabetic State

Rhizoma Coptidis, Radix Astragali and Flos Lonicerae

Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix

Effects of TCM on Beta-cell Function and Insulin Resistance in High Risk Chinese Individuals for T2D (TCM_PDiab_P01)

Effects of a Novel Formulation of Traditional Chinese Medicine (TCM) For Prevention of Type 2 Diabetes (T2D)

Plasma glucose during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period

Plasma insulin during 75g OGTT will be measured at baseline, after 12 weeks treatment and 12 weeks of treatment period

Measure blood pressure at baseline, after 12 weeks treatment and 12 weeks of treatment period

Measure body weight at baseline, after 12 weeks treatment and 12 weeks of treatment period

Measure renal function test by measuring Serum creatinine test at baseline, after 12 weeks treatment and 12 weeks of treatment period

Measure liver function test by measuring the change of Alanine transaminase (ALT) test at baseline, after 12 weeks treatment and 12 weeks of treatment period

investigate the proportion of reversal from pre-diabetes to euglycaemia by assessing number euglycaemic subject after 12 weeks on treatment and 12 weeks off treatment period

Juliana Chan

Professor

Chinese University of Hong Kong

Ever-use of incretin-based drugs ((DPP-4 inhibitors [sitagliptin, vildagliptin, and saxagliptin] or GLP-1 analogs [exenatide, liraglutide]) between (and including) base cohort entry and the index day - 365 days.

Ever-use of sulfonylureas between (and including) base cohort entry and the index day - 365 days, and never-use of incretin-based drugs.

Ever-use of other antidiabetic agents (biguanides, thiazolidinediones, alpha-glucosidase inhibitors, meglitinides) between (and including) base cohort entry and the index day - 365 days, with never-use of incretin-based drugs and never use of sulfonylureas.

Diabetes Mellitus, Type 2

Ever-use of DPP-4 inhibitors (ATC A10BH, A10BD07-A10BD13) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.

DPP-4 inhibitors

Ever-use of GLP-1 analogs (ATC A10BX04, A10BX07) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.

GLP-1 analogs

Ever-use of sulfonylureas (ATC A10BB or A10BC) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.

Sulfonylureas

Ever-use of biguanides (ATC A10BA) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.

Biguanides

Ever-use of thiazolidinediones (ATC A10BG) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.

Thiazolidinediones

Ever-use of alpha-glucosidase inhibitors (ATC A10BF) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.

Alpha-glucosidase inhibitors

Ever-use of meglitinides (ATC A10BX02, A10BX03) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.

Meglitinides

This organization's website describing general functions, other CNODES projects, and investigator profiles.

Lady Davis Institute for Medical Research, Jewish General Hospital

Incretin-based Drugs and Pancreatic Cancer

The Use of Incretin-based Drugs and the Risk of Pancreatic Cancer in Patients With Type 2 Diabetes

Incident cases of pancreatic cancer recorded in a hospital database with the following ICD codes:
ICD-9:157.0-157.9
ICD-10:C25.x

Canadian Network for Observational Drug Effect Studies, CNODES

Drug Safety and Effectiveness Network, Canada

Canadian Institutes of Health Research (CIHR)

2 tablets three times daily, oral for 16 weeks

three times daily, oral for 16 weeks
BTI320: 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 4 Grams

BTI320 8 Grams

2 tablets three times daily, oral for 16 weeks
BTI320 matching placebo: Placebo

BTI320 Matching Placebo

Total

Sex: Female, Male

Region of Enrollment

Body weight

Body mass index

Waist circumference

Systolic blood pressure

Diastolic blood pressure

Fructosamine

HbA1c

Total cholesterol

Impaired fasting glucose

Impaired glucose tolerance

Impaired fasting glucose and impaired glucose tolerance

Normal glucose tolerance

1-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system

1-hour post-prandial glucose AUC

2-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system

2-hour post-prandial glucose AUC

3-hour post-prandial glucose incremental area under curve on continuous glucose monitoring system

3-hour post-prandial glucose AUC

Area under curve for glucose levels >180 mg/dL on continuous glucose monitoring system

72 hour AUC-180

Mean blood glucose on continuous glucose monitoring system

Mean blood glucose

Mean post-meal maximum glucose on continuous glucose monitoring system

Mean post-meal maximum glucose

Mean amplitude of glucose excursion on continuous glucose monitoring system

Mean amplitude of glucose excursion

Percentage coefficient of variation on continuous glucose monitoring system

Percentage coefficient of variation

Standard deviation on continuous glucose monitoring system

Standard deviation

Change in Serum Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo

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.

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 Subjects Treated With Low Dose BTI320 and High Dose BTI320 Compared With Placebo in Mean Post-meal Maximum Glucose on Continuous Glucose Monitoring System

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

Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Mean Blood Glucose on Continuous Glucose Monitoring System

Area under curve for glucose levels >180 mg/dL over 72 hours

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

Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Standard Deviation of Glucose on Continuous Glucose Monitoring System

Changes in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo in Percent Coefficient of Variation on Continuous Glucose Monitoring System

Changes in HbA1c in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo

Changes in Fructosamine in Subjects Treated With Low Dose and High Dose BTI320 Compared With Placebo

Changes in area under curve of glucose from 0 minute to 120 minutes 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 insulin from 0 minute to 120 minutes 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 C-peptide from 0 minute to 120 minutes 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 glucagon-like peptide-1 from 0 minute to 120 minutes 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

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

Proportion of Subjects With Impaired Fasting Glucose or Impaired Glucose Tolerance in Low Dose BTI320, High Dose BTI320 and Placebo Group

Changes in systolic blood pressures from baseline to Week 16

Changes in Blood Pressures in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Changes in Waist Circumference in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Changes in Body Weight in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Changes in total cholesterol from baseline to Week 16.

Changes in Lipids in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Changes in High-sensitivity C-reactive Protein in Subjects Treated With High Dose and Low Dose BTI320 Compared Placebo

Changes in Urate in Subjects Treated With High Dose and Lose 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.

Changes in Quality of Life Measures 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.

Changes in Measures of Food Satiety in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Changes in daily calories intake 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 the number of days per week that the subject spent walking for at least 10 minutes 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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Changes in Serum Creatinine in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Changes in Measures of Liver Function in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Changes in Complete Blood Count in Subjects Treated With High Dose and Low Dose BTI320 Compared to Placebo

Overall Study

Dr Andrea Luk

Pre-Diabetes

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.

alpha glucosidase/krabbamein

Effects of TCM on Beta-cell Function and Insulin Resistance in High Risk Chinese Individuals for T2D (TCM_PDiab_P01)

Incretin-based Drugs and Pancreatic Cancer

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

Heillasta gagnagrunnur lækningajurtanna sem studdur er af vísindum