Evaluation of Fuling Yunhua Granules and Dihuang Baoyuan Granules in Drug Naive Type 2 Diabetes Patients

NCT06575478 | Recruiting Phase 2 DMC

• 1 other identifier: JYHS-BAIIT-Pro-24001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this investigator-initiated clinical trial is to investigate the efficacy and safety of sequential therapy of Fuling Yunhua Granules (prescription A) and Dihuang Baoyuan Granule (prescription B) in the treatment of type 2 diabetes patients with poor glycemic control after diet and exercise intervention.

Conditions

Diabetes Mellitus, Type 2; Diabetes; Type2diabetes

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c concentrations (%) from baseline

  Change in HbA1c concentrations (%) from baseline

  12 weeks

Secondary Outcomes (8)

• Change in FPG (mmol/L) from baseline

  12 weeks

• The proportion of participants who achieved HbA1c target

  12 weeks

• Changes in TIR from baseline

  7 days

• Changes in TBR from baseline

  7 days

• Changes in TAR from baseline

  7 days

Study Arms (4)

prescription ABA

EXPERIMENTAL

Fuling Yunhua Granules and Dihuang Baoyuan Granules

Drug: Fuling Yunhua Granules

prescription ABA-matched placebo

PLACEBO COMPARATOR

Fuling Yunhua Granules placebo and Dihuang Baoyuan Granules placebo

Drug: Fuling Yunhua Granules matched placebo

prescription BAB

EXPERIMENTAL

Fuling Yunhua Granules and Dihuang Baoyuan Granules

Drug: Dihuang Baoyuan Granules

prescription BAB-matched placebo

PLACEBO COMPARATOR

Fuling Yunhua Granules placebo and Dihuang Baoyuan Granules placebo

Drug: Dihuang Baoyuan Granules matched placebo

Interventions

Fuling Yunhua Granules DRUG

Fuling Yunhua Granules

Also known as: prescription A

prescription ABA

Fuling Yunhua Granules matched placebo DRUG

Fuling Yunhua Granules placebo

Also known as: prescription A matched placebo

prescription ABA-matched placebo

Dihuang Baoyuan Granules DRUG

Dihuang Baoyuan Granules

Also known as: prescription B

prescription BAB

Dihuang Baoyuan Granules matched placebo DRUG

Dihuang Baoyuan Granules placebo

Also known as: prescription B matched placebo

prescription BAB-matched placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years (inclusive), male or female;
• Patients diagnosed with T2DM ≥ 8 weeks according to the 2020 WHO diagnostic criteria and classification;
• Have controlled blood sugar through diet and exercise for 3 months before screening and did not receive any hypoglycemic drugs, or used hypoglycemic drugs for no more than 2 weeks within 3 months before screening and did not use hypoglycemic drugs within 1 month before screening;
• Body mass index (BMI) ≥ 19 kg/m2;
• Glycated hemoglobin (HbA1c) ≥ 7.0% and \< 10.5% at screening;
• Fasting plasma glucose (FPG) \< 13.9 mmol/L at screening;
• Able to understand the procedures and methods of this study, willing to strictly abide by the clinical research protocol to complete this study, and voluntarily sign the ICF

You may not qualify if:

• Non-type 2 diabetes: type 1 diabetes, gestational diabetes, special types of diabetes;
• History of acute complications of diabetes within 6 months before screening (diabetic ketoacidosis, diabetic hyperglycemic hyperosmolar syndrome or lactic acidosis, etc.);
• History of chronic complications of diabetes with unstable condition or requiring treatment within 6 months before screening (proliferative retinal disease, severe diabetic neuropathy or intermittent claudication, etc.);
• Experienced more than 3 episodes of grade 3 hypoglycemia within 6 months before screening;
• Have used systemic (intravenous, oral or intra-articular) glucocorticoids continuously or cumulatively for ≥ 7 days within 3 months before screening;
• Severe infection within 3 months before screening;
• Diagnosed with malignant tumors within 5 years before screening (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
• Severe cardiovascular disease, such as heart failure (New York Heart Association \[NYHA\] grade III-IV), myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention, occurred within 6 months before screening, Sustained and clinically significant arrhythmia (such as second- or third-degree atrioventricular block or QTc interval prolongation ≥470 ms in men and ≥480 ms in women), acute coronary syndrome or transient ischemic attack or stroke wait;
• Suffering from diseases that may significantly affect drug absorption, distribution, metabolism and excretion within 6 months before screening: inflammatory bowel disease, peptic ulcer, history of gastrointestinal or rectal bleeding, history of important gastrointestinal surgery (such as : Gastrectomy, gastrointestinal anastomosis, or intestinal resection), etc.;
• Accompanied by thyroid dysfunction that cannot be controlled with stable drug dosage during screening;
• History of hypertension and take antihypertensive treatment regularly for more than 4 weeks but still have poor blood pressure control, with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg;
• History of organ transplantation or severe autoimmune diseases in the past or present;
• History of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis);
• History of major surgery (intrathoracic, intracranial, abdominal, etc.) within 6 months before screening, or those who plan to undergo surgery during the study that may affect study completion or compliance;
• Any laboratory test meets any of the following criteria during screening:

Sponsors & Collaborators

• Beijing Supreme Life Pharmaceutical Technology Co., Ltd.: lead
• Peking University People's Hospital: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Qian Ren

CONTACT

00861088324105; qianren_xuan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 28, 2024
• Study Start: July 31, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)