Efficacy and Safety of Sanggua Tablets in the Treatment of Patients With Impaired Glucose Tolerance and Mild Type 2 Diabetes

NCT06964620 | Recruiting Early Phase 1 DMC

• 1 other identifier: 20241010
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus (T2DM) and impaired glucose tolerance (IGT) are growing public health challenges. Early intervention in mild T2DM and IGT is essential to prevent disease progression and severe complications. Traditional Chinese Medicine (TCM) provides a potential therapeutic approach. Sanggua tablets, a TCM formula composed of mulberry leaf, bitter melon, kudzu root, Chinese yam, and cassia seed, embody TCM principles of clearing heat, generating body fluids, tonifying the spleen and stomach, and nourishing the lungs and kidneys. Modern studies show that Sanggua tablets effectively lower blood glucose and improve lipid profiles through components like mulberry polysaccharides and bitter melon saponins. These findings suggest their potential as an alternative or complementary therapy for mild T2DM and IGT. This study will conduct a randomized, double-blind, placebo-controlled, parallel-group clinical trial among patients with IGT and mild T2DM. Participants will receive a 16-week intervention with Sanggua tablets. The primary outcome is glycated hemoglobin (HbA1c), with secondary outcomes such as fasting blood glucose (FBG), fasting insulin (FINS), HOMA-IR, lipid profiles and so on. Safety will be closely monitored. Additionally, fecal samples will be collected for 16S rDNA sequencing to explore the role of gut microbiota in the therapeutic effects of Sanggua tablets. This study aims to provide evidence for the clinical application and development of Sanggua tablets as a novel TCM therapy.

Conditions

Diabetes Mellitus, Type 2; Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c, %)

  The percentage of glycated hemoglobin in the blood will be determined to evaluate the hypoglycemic effect of Sanggua tablets. Evaluate the degree of reduction in glycated hemoglobin after the end of the treatment period of the patients and the rate of reduction among the 84 enrolled patients.

  The percentage of glycated hemoglobin will be measured at baseline (V1) and at the end of the treatment period(Week 16 ,V5).

Secondary Outcomes (57)

• Fasting blood glucose (FBG, mmol/L)

  FBG will be measured at the following time points during the clinical trial: enrollment visit (V1), Week 4 (V2), Week 8 (V3), Week 12 (V4), and Week 16 (V5).

• 2 hour blood glucose (mmol/L)

  FBG will be measured at the following time points during the clinical trial: enrollment visit (V1), Week 4 (V2), Week 8 (V3), Week 12 (V4), and Week 16 (V5).

• Fasting insulin (FINS, uIU/ml)

  FINS will be measured at baseline (V1) and at the end of the treatment period(Week 16 ,V5).

• 2 hour insulin (uIU/ml)

  FINS will be measured at baseline (V1) and at the end of the treatment period(Week 16 ,V5).

• Fasting C-peptide(ug/L)

  C-peptide will be measured at baseline (V1) and at the end of the treatment period(Week 16 ,V5).

Study Arms (2)

Conventional treatment plus Sanggua tablets

EXPERIMENTAL

Conventional treatment plus Sanggua tablets (0.75 g per tablet, twice daily, bid) for 16 weeks

Drug: Sanggua tablets

Conventional treatment plus placebo

PLACEBO COMPARATOR

Conventional treatment plus placebo (0.75 g per tablet, twice daily, bid) for 16 weeks.

Drug: Placebo

Interventions

Sanggua tablets DRUG

Patients will continue their background medications and receive Sang Gua tablets, twice daily (bid).

Conventional treatment plus Sanggua tablets

Placebo DRUG

Patients will continue their background medications and receive placebo, twice daily (bid).

Conventional treatment plus placebo

Eligibility Criteria

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

You may qualify if:

• Patients aged 18-70 with impaired glucose tolerance (IGT).
• Patients aged 18-70 diagnosed with type 2 diabetes mellitus (T2DM) deemed by the clinician not requiring pharmacological intervention.
• Glycated hemoglobin (HbA1c) levels between 5.6% and 7.5%.
• Voluntarily sign an informed consent form before the commencement of trial-related activities, understand the procedures and methods of the trial, and are willing and able to strictly adhere to the clinical trial protocol to complete the study.

You may not qualify if:

• Type 1 diabetes mellitus.
• Known allergies to Sang Gua tablets or any of its components.
• Use of hypoglycemic or lipid-lowering drugs within the last three months.
• Presence of severe primary or secondary respiratory, cardiovascular, hepatic, or renal diseases, rheumatic connective tissue diseases, or hematological disorders.
• Uncontrolled or unstable conditions exacerbated by infections, severe electrolyte imbalances, or other factors.
• Patients with primary or secondary kidney diseases, hypertension, heart failure, acidosis, or urinary tract infections causing increased urinary protein, excepted.
• Patients with psychiatric disorders.
• Pregnant or planning to become pregnant women, or nursing mothers.
• Patients requiring long-term steroid therapy.
• Patients with poorly controlled hypertension or secondary hypertension.
• Patients who have participated in other clinical trials within the past three months.
• Patients deemed by the investigator as unsuitable for this clinical trial due to potential interference with trial results, impediments to full participation in the study, medical history, disease evidence, abnormal treatments, or laboratory values, or any other condition considered by the investigator to pose potential risks for participation in the study.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Officials

• Gang Yuan, Professor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Yuan, Professor

CONTACT

0086-027-13871523102; gangyuan@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: May 9, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): November 24, 2027
• Study Completion (Estimated): December 25, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

CN (1)