Novel Chinese Medicine Formula for Diabetes

Prior treatment

• Individuals using warfarin or other medications which may cause herb-drug interactions as judged by the investigator
• Use of weight loss drugs currently or within 1 month before first dose
• Previous metabolic surgery
• Use of any investigational drug within 3 months prior to screening
• Use of any sensitive substrates or organic anion transporter (OAT) 1 or 2, or inhibitors of OAT1 or OAT2 from randomization to the study close out visit (Examples of OAT1 substrates include adefovir, ciprofloxacin, furosemide, tenofovir. Examples of OAT2 substrate include metformin. Examples of OAT1 inhibitors include probenecid. Examples of OAT2 inhibitors include cimetidine, dolutegravir, isavuconazole, ranolazine).
• Use of any P-gp substrates or P-gp inhibitors from randomization to the study close out visit (Examples of P-gp substates include digoxin, fexofenadine, dabigatran etexilate, edoxaban. Examples of P-gp inhibitors include amiodarone, clarithromycin, erythromycin, itraconazole, ketoconazole, cobicistat, cyclosporine, dronedarone, lapatinib, lopinavir and ritonavir)

Other illness

• History of drug abuse or excessive alcohol intake based on investigator judgment
• Individuals with severe infection, in perioperative period or with serious injury at the time of recruitment
• Individuals with known G6PD deficiency or known history of herb-drug interactions
• Known history of thyroid disorders
• History of clinically significant drug hypersensitivity reactions
• Any conditions considered unsuitable by the investigators

Lab values

• Significant medical history including but not limited to history of cardiovascular disease (stroke, ischaemic heart disease, peripheral vascular disease) within the last 6 months, estimated glomerular filtration rate (eGFR) \<60 ml/min/1.73m2 and/or liver dysfunction (AST and/or ALT≥1.5 times upper limit of normal)
• Individuals with blood haemoglobin outside the normal range (male: 13.5-17.5 g/dl and female: 12.0-15.5 g/dl)
• Use of dietary supplements or health products which might affect glucose metabolism or body weight within 1 month before first dose, as judged by the investigator
• HbA1c \>8.0% at screening, treated or untreated
• Use of any glucose lowering drugs

Other

• Not willing to participate in the study or adhere to study procedures
• Dehydration, diarrhea or vomiting at the time of recruitment
• Breast feeding, pregnant women or women with plans for pregnancy
• Use of any OATP1B1 transporter substrates from randomization to the study close out visit (Examples include atorvastatin, lovastatin, pitavastatin, pravastatin, glyburide, paclitaxel, exofenadine, elagolix, docetaxel, bosentan).
• BP ≥140 mmHg (systolic) or 90 mmHg (diastolic) treated or untreated.

• Diabetes based on 1) HbA1c≥6.5% OR 2) 75-gram OGTT (fasting PG ≥7 mmol/L or 2-h PG≥11.1 mmol/L) with 2 abnormal values in individuals without symptoms or 1 abnormal value in individuals with symptoms
• HbA1c≤8%
• Age ≥18 years - 70 years (inclusive)
• Body mass index (BMI) ≥18 kg/m2
• Chinese ethnicity
• Duration of T2D (no history of ketosis or continuous requirement of insulin within 12 months of diagnosis) ≤ 6 years
• Not on any glucose lowering drugs for the last 3 months