Status:
NOT_YET_RECRUITING
Novel Chinese Medicine Formula for Diabetes
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Diabetes is a leading cause of heart disease, stroke, kidney failure, cancer and premature death. One in 10 adults are affected by diabetes. Early control of high blood gluocse prevents progressive de...
Detailed Description
People with impaired insulin secretion from the pancreatic beta-cells is the main cause of type 2 diabetes (T2D). This can be demonstrated by measuring insulin secretion following an 75 gram oral gluc...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- Not willing to participate in the study or adhere to study procedures
- 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)
- History of drug abuse or excessive alcohol intake based on investigator judgment
- Dehydration, diarrhea or vomiting at the time of recruitment
- Individuals with severe infection, in perioperative period or with serious injury at the time of recruitment
- 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
- Breast feeding, pregnant women or women with plans for pregnancy
- Individuals using warfarin or other medications which may cause herb-drug interactions as judged by the investigator
- Individuals with known G6PD deficiency or known history of herb-drug interactions
- HbA1c \>8.0% at screening, treated or untreated
- Use of weight loss drugs currently or within 1 month before first dose
- Use of any glucose lowering drugs
- Previous metabolic surgery
- Known history of thyroid disorders
- History of clinically significant drug hypersensitivity reactions
- 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 OATP1B1 transporter substrates from randomization to the study close out visit (Examples include atorvastatin, lovastatin, pitavastatin, pravastatin, glyburide, paclitaxel, exofenadine, elagolix, docetaxel, bosentan).
- 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)
- BP ≥140 mmHg (systolic) or 90 mmHg (diastolic) treated or untreated.
- Any conditions considered unsuitable by the investigators
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06978023
Start Date
May 1 2025
End Date
February 1 2027
Last Update
May 18 2025
Active Locations (1)
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1
Department of Medicine and Therapeutics, The Chinese University of Hong Kong (CUHK), Ward 3M, Diabetes and Endocrine Research Centre, 3/F Day Treatment Block and Children Wards (Old Block), Prince of Wales Hospital
Hong Kong, Hong Kong