Novel Chinese Medicine Formula for Diabetes

May 16, 2025 updated by: Juliana Chan, Chinese University of Hong Kong

Clinical Safety, Efficacy and Multiomic Evaluation of a Novel Chinese Medicine Formula in Type 2 Diabetes: Effects on Beta-cell Function and Insulin Resistance

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 glucose tolerance test (OGTT) or a mixed meal tolerance test (MMTT). Other pathophysiological processes underlying diabetes include non-suppression of glucagon from pancreatic alpha-cells with increased fasting blood glucose, abnormal incretin (e.g. glucagon like peptide GLP1) secretion from gut which augment insulin secretion during food intake as well as changes in gut microbiota which can interact with foods and medicine to alter hormonal secretion and metabolic milieu. Obesity, hyperglycaemia and dyslipidemia can alter inflammatory pathways, transcription factors and oxidative stress resulting in further impairment of insulin secretion and its actions. Early attainment of glycemic control can break these vicious cycles, improve glycemic durability and reduce progressive treatment escalation.

Several randomized controlled trials (RCTs) and meta-analyses indicate that TCM containing multiple active components may prevent and control diabetes in human. In animal studies, our group first reported that a combination of extracts from 3 herbs (Coptidis Rhizoma; Astragali Radix; Lonicerae Japonicae Flos, abbreviated as CAL) lowered blood glucose in diabetic rats with sustained improvement in insulin resistance and beta-cell function accompanied by resolution of fatty liver. These effects persisted for weeks or months after treatment discontinuation depending on treatment duration. These improvements were accompanied by changes in gene expression (RNA and microRNA) implicated in energy metabolism. In another animal study, we first reported that extracts from Ophiopogonis (Oph) increased insulin secretion, reduced inflammation and expanded islet mass with lowering of blood glucose.

Based on these mechanistic studies, we designed a proprietary formula consisting of CAL plus Oph (referred as Jinmai, JM). We randomized people with prediabetes to recieve 12-week treatment with 1) CAL only, 2) CAL+Oph low dose (JM-LD), 3) CAL+Oph very low dose (JM-VLD) and 4) consultation with CM practitioners (control), followed by treatment discontinuation for 12 weeks. Amongst these 4 groups, participants treated with JM-LD had signficant reduction in blood glucose and increased insulin secretion during 75 gram OGTT. This effect was sustained after discontinuation of JM-LD for 3 months. Microbiota and RNA analysis indicated that JM-LD caused favorable changes in microbiota and gene expression which correlated with these metabolic changes.

Based on these consistent evidence, we produced a proprietary JM formula consisting of a fixed combination of extracts of CAL with low dose (JM-LD) or high dose extracts of Oph (JM-HD) under good manufacturing practice. The study was approved by the Hong Kong Department of Health for investigational use aimed at registering JM as a novel CM for prevention and treatment of T2D.

Hypothesis:

A 24-week treatment with JM in people with T2D reduce glucose excursion and improve beta-cell function through changes in gut microbiota and gene expression

Study design:

A double-blind, placebo-controlled RCT to assess the efficacy, safety and multiomic effects of JM and its optimal dose in people with early T2D (within 6 years) not treated with glucose lowering drugs.

Intervention:

Randomized in a 1:1:1 ratio to receive 24-week treatment with

  1. JM-LD in powder form (13.5 g twice daily) to be dissolved in 250 ml of hot water
  2. JM-HD in powder form (13.5 g twice daily) to be dissolved in 250 ml of hot water or
  3. matching placebo in powder form (13.5 g twice daily) to be dissolved in 250 ml of hot water followed by treatment discontinuation for 3 months

Primary objective:

To compare changes in glucose excursion during MMTT after 24 week treatment with JM-LD or JM-HD compared to placebo

Secondary objectives:

  1. To evaluate the sustained effect of JM on glucose exursion during MMTT 12 weeks after JM discontinuation compared to placebo
  2. To compare changes in cardiometabolic risk factors including blood pressure, lipids and body weight and HbA1c as well as insulin secretion and resistance during MMTT after 24 weeks of JM treatment compared to placebo
  3. To compare changes in biomarkers and multiomics and their correlations with metabolic changes after 24 weeks of JM treatment compared to placebo

Primary outcome measure:

Between-group difference in area-under-the-curve of plasma glucose (AUC-PG) during MMTT in the JM group versus changes in the placebo group (difference-difference) from week 0 to 24 (on treatment)

Sample size:

In the aforementioned 12-week study of JM versus placebo in people with prediabetes, the mean (SD) of AUC-PG during OGTT in placebo group was 18.9 (1.8) mmol/L/min. The AUC-PG was 1.89 mmol/L/min, i.e. 10% lower in the JM-LD group than the placebo group. Based on a conservative estimation of a superiority margin of 0.945 (5% of mean difference) in favor of JM-HD versus placebo, 45 participants in each arm are needed to achieve an 80% power at one-sided significance level of 5%. Allowing a 20% drop out rate, we shall assign 54 participants to each of 3 groups with a total of 162 participants.

Study site:

The study will be conducted at Ward 3M, Diabetes and Endocrine Research Centre, Prince of Wales Hospital in accordance with Declaration of Helsinki, and Good Clinical Practice (GCP) and Standard Operation Procedures (SOP) stipulated by the CUHK-NTEC Clinical Research Management Office

Significance of the study:

This double-blind placebo-controlled RCT will provide data in support of the beneficial effects of a novel proprietary CM formula (JM) on glycemic excursion in people with early T2D as a therapeutic option. The effects of JM on beta-cell function, insulin resistance, biomarkers, multiomics and gut microbiota will explain the mechanisms underlying the benefits of JM. These data will provide the basis for conduct of large-scale study to examine the effects of JM in the prevention of T2D and its progression to non-communicable diseases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • 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
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juliana CN Chan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JM-LD group
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
Proprietary formula of extracts of Coptidis Rhizoma, Astragali Radix Lonicerae Japonicae Flos (CAL) plus low dose extract of Ophiopogonis Radix
Other Names:
  • Jinmai (CAL+ low dose Ophiopogonis Radix)
Experimental: JM-HD group
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
Proprietary formula of extracts of Coptidis Rhizoma, Astragali Radix, Lonicerae Japonicae Flos (CAL) plus high dose extract of Ophiopogonis Radix
Other Names:
  • Jinmai (CAL+ high dose Ophiopogonis Radix)
Placebo Comparator: Placebo group
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
Placebo consisting of excipients, coloring and food ingredients to provide a powder mixture of same weight with similar color, texture and odour

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference-difference in glycemic excursion during MMTT after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference-difference in glycemic excursion during MMTT 12 weeks off JM treatment
Time Frame: From Week-24 to Week-36 (off treatment)
Between-group difference in AUC-PG during 2-hour MMTT in JM group versus changes in placebo group
From Week-24 to Week-36 (off treatment)
Difference-difference in insulin resistance after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in HOMA-IR in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in beta cell function after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in HOMA-beta in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in insulin secretion after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in insulinogenic index derived from PG and insulin measured during MMTT in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in insulin sensitivity after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in quantitative insulin sensitivity check index (QUICKI) derived from PG and insulin measured during MMTT in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in body mass index (BMI) after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in BMI in JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in blood pressure after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in blood pressure in JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in non-HDL cholesterol after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in non-HDL cholesteroal in JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in HbA1c after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in HbA1c in JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in waist circumference after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in waist circumference in JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in blood haemoglobin after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in blood haemoglobin in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in estimated glomerular filtration rate (eGFR) after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in ichanges in eGFR in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in serum alanine transferase after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in serum alanine transferase in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in serum alkaline phosphatase after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in ichanges in serum alkaline phosphatase in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in serum bilirubin after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in serum bilirubin in the JM group versus changes in placebo group
From Week-0 to Week-24
Difference-difference in EQ5D index after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in EQ5D as index of quality of life in the JM group versus changes in the placebo group
From Week-0 to Week-24

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference-difference in glucagon like peptide (GLP-1) after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in GLP-1 in the JM group versus changes in the placebo group
From Week-0 to Week-24
Difference-difference in gut microbiome after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in microbiome in the JM group versus changes in the placebo group
From Week-0 to Week-24
Difference-difference in blood RNA expression after 24 weeks of JM treatment
Time Frame: From Week-0 to Week-24
Between-group difference in changes in RNA expression in the JM group versus changes in the placebo group
From Week-0 to Week-24
Relationships between metabolic and multiomic changes
Time Frame: From Week-0 to Week-24
Correlations between changes in outcome measures and changes in microbiome and RNA
From Week-0 to Week-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juliana CN CHAN, MD, CUHK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JM_RCT_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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