Novel Chinese Medicine Formula for Diabetes

NCT06978023 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: JM_RCT_2024
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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 deterioration and treatment escalation. People with diabetes have impaired insulin secretion, the only hormone that can lower blood glucose, or resistance to insulin action. There are trillions of microrganisms (tiny living things including bacteria) in the gut that can interact with foods and medicine to alter bodily functions including insulin secretion and its actions. Studies in animals and human suggested that a Traditional Chinese Medicine (TCM) containing a combination of four herbs (Jinmai, abbreviated as JM) reduced blood glucose by increasing insulin secretion accompanied by favorable changes in gut bacteria and expression of genetic information that regulate bodily functions. In this study, people with type 2 diabetes diagnosed for less than 6 years and not treated with any glucose lowering drugs are assigned randomly to recieve 1) high dose JM (JM-HD) or 2) low dose JM (JM-LD) or 3) look-alike dummy (placebo) given in powder form to be dissolved in water taken twice daily for 24 weeks. We shall compare the abilities of these 3 combination products to lower blood glucose over a 2-hour period after taking a nutritional drink at 0, 12 and 24 weeks. The assigned treatment will then be discontinued for 12 weeks and the test will be repeated to see if improvement is sustained. Samples will be collected at week 0 and 24 (on-treatment) and week 36 (12 weeks off-treament) to compare changes in gut bacteria in faeces and expression of genetic information that make proteins which regulate blood glucose amongst these 3 groups.

Conditions

Type 2 Diabetes

Keywords

diabetes; Chinese medicine; insulin; multiomic

Outcome Measures

Primary Outcomes (1)

• Difference-difference in glycemic excursion during MMTT after 24 weeks of JM treatment

  Between-group difference in changes in area under the curve of plasma glucose (AUC-PG) during 2-hour MMTT in JM group versus changes in the placebo group

  From Week-0 to Week-24

Secondary Outcomes (16)

• Difference-difference in glycemic excursion during MMTT 12 weeks off JM treatment

  From Week-24 to Week-36 (off treatment)

• Difference-difference in insulin resistance after 24 weeks of JM treatment

  From Week-0 to Week-24

• Difference-difference in beta cell function after 24 weeks of JM treatment

  From Week-0 to Week-24

• Difference-difference in insulin secretion after 24 weeks of JM treatment

  From Week-0 to Week-24

• Difference-difference in insulin sensitivity after 24 weeks of JM treatment

  From Week-0 to Week-24

Other Outcomes (4)

• Difference-difference in glucagon like peptide (GLP-1) after 24 weeks of JM treatment

  From Week-0 to Week-24

• Difference-difference in gut microbiome after 24 weeks of JM treatment

  From Week-0 to Week-24

• Difference-difference in blood RNA expression after 24 weeks of JM treatment

  From Week-0 to Week-24

Study Arms (3)

JM-LD group

EXPERIMENTAL

Name: JM-LD packed in illumina foil Form: powder dissolved in 250 ml hot water Dosage 13.5 g per packet Frequency: twice daily Duration: 24 weeks

Combination Product: JM-LD

JM-HD group

EXPERIMENTAL

Name: JM-HD packed in illumina foil Form: powder dissolved in 250 ml hot water Dosage 13.5 g per packet Frequency: twice daily Duration: 24 weeks

Combination Product: JM-HD

Placebo group

PLACEBO COMPARATOR

Name: Placebo in illumina foil Form: powder dissolved in 250 ml hot water Dosage 13.5 g per packet Frequency: twice daily Duration: 24 weeks

Combination Product: Placebo

Interventions

JM-LD COMBINATION_PRODUCT

Proprietary formula of extracts of Coptidis Rhizoma, Astragali Radix Lonicerae Japonicae Flos (CAL) plus low dose extract of Ophiopogonis Radix

Also known as: Jinmai (CAL+ low dose Ophiopogonis Radix)

JM-LD group

JM-HD COMBINATION_PRODUCT

Proprietary formula of extracts of Coptidis Rhizoma, Astragali Radix, Lonicerae Japonicae Flos (CAL) plus high dose extract of Ophiopogonis Radix

Also known as: Jinmai (CAL+ high dose Ophiopogonis Radix)

JM-HD group

Placebo COMBINATION_PRODUCT

Placebo consisting of excipients, coloring and food ingredients to provide a powder mixture of same weight with similar color, texture and odour

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (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

Location

Related Publications (2)

• Zhao HL, Sui Y, Qiao CF, Yip KY, Leung RK, Tsui SK, Lee HM, Wong HK, Zhu X, Siu JJ, He L, Guan J, Liu LZ, Xu HX, Tong PC, Chan JC. Sustained antidiabetic effects of a berberine-containing Chinese herbal medicine through regulation of hepatic gene expression. Diabetes. 2012 Apr;61(4):933-43. doi: 10.2337/db11-1164. Epub 2012 Mar 6.

  PMID: 22396199 BACKGROUND

• Mao D, Tian XY, Mao D, Hung SW, Wang CC, Lau CBS, Lee HM, Wong CK, Chow E, Ming X, Cao H, Ma RC, Chan PKS, Kong APS, Li JJX, Rutter GA, Tam WH, Chan JCN. A polysaccharide extract from the medicinal plant Maidong inhibits the IKK-NF-kappaB pathway and IL-1beta-induced islet inflammation and increases insulin secretion. J Biol Chem. 2020 Sep 4;295(36):12573-12587. doi: 10.1074/jbc.RA120.014357. Epub 2020 Jun 30.

  PMID: 32605924 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Juliana CN CHAN, MD

  CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juliana CN Chan, MD

CONTACT

+85235053138; jchan@cuhk.edu.hk

Chun-Kwan O, MBChB

CONTACT

+85235051549; chunkwano@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 18, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)