YH1 in Poorly Controlled Type 2 Diabetes

NCT02752880 | Completed Phase 2 Results

• 1 other identifier: 104-7934A3,105-7009C,106-0917C
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus is a chronic metabolic disease that seriously affects patients worldwide, and it is always among the top 10 causes of death in Taiwan. To date, still many patients who take more than three kinds of oral hypoglycemic agents could not effectively control their glycohemoglobin levels in clinics. Hypoglycemia as well as weight gain are common side effect with insulin therapy, and many patients in Taiwan are not willing to receive insulin injection. It is common for diabetic patients treated with Chinese herbal medicine in China currently, and some therapeutic effects have been published in international journals. In this study, we will evaluate whether Chinese herbal medicine, YH1, enhances the glycemic control and is safe as add-on medication in poorly controlled type 2 diabetes patients. A total of 46 poorly controlled type 2 diabetes patients with glycohemoglobin ≥ 7% from Endocrinology and Metabolism clinics or Internal Chinese Medicine clinics will be enrolled in this randomized double-blind placebo-controlled trial. Subjects will be randomly assigned to receive either YH1 (6 g) or the placebo three times per day for 12 consecutive weeks. All subjects in both groups will also continuously receive their oral hypoglycemic agents without any dose or medicine change. During this 12-week period, the glycohemoglobin, fasting plasma glucose, 2h postprandial glucose, waist circumference, body weight, and body mass index will be assessed. In addition, insulin resistance, β -cell function, lipid profile, liver and renal function will also be evaluated. Independent statisticians will perform the data analysis at the end of the trial.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• The Percentage Change in HbA1c Level From Baseline to 12 Weeks

  The primary efficacy endpoint was the percentage change in HbA1c levels from baseline to 12 weeks. The HbA1c level was measured by HPLC in the Department of Laboratory Medicine at Chang Gung Memorial Hospital.

  12 weeks

Secondary Outcomes (1)

• The Percentage Change in 2hPG From Baseline to Week 12

  12 weeks

Study Arms (2)

YH1 group

EXPERIMENTAL

YH1 with one batch number was manufactured by Sun Ten Pharmaceutical Co., Ltd., a renowned manufacturer of concentrated herbal extract granules conforming to the standards of good manufacturing practices (GMP) in New Taipei City, Taiwan. YH1 contains Rhizoma Coptidis (50 %) and Shen-Ling-Bai-Zhu-San (SLBZS) (50 %). SLBZS consists of Radix Ginseng, Poria, Rhizoma Atractylodis macrocephalae, Semen Lablab album, Rhizoma Dioscoreae, Embryo Nelumbinis, Radix Platycodonis, Semen Coicis, Fructus Amomi, Fructus Jujubae, and Radix Glycyrrhizae at a 3:3:3:2.3:3:1.5:1.5:1.5:1.5:1.5:3 ratio. Subjects in the YH1 group orally ingested two packages of granules (3 g/package) three times daily with warm water after a meal for 12 consecutive weeks.

Drug: YH1 group

placebo group

PLACEBO COMPARATOR

The placebo was also prepared as granules by Sun Ten Pharmaceutical Co., Ltd., and the packaging of the placebo was identical to that of YH1. Subjects in the placebo group orally ingested two packages of granules (3 g/package) three times daily with warm water after a meal for 12 consecutive weeks.

Drug: placebo group

Interventions

YH1 group DRUG

Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.

Also known as: Rhizoma Coptidis and Shen-Ling-Bai-Zhu-San

YH1 group

placebo group DRUG

Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.

placebo group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age;
• Diagnosed as type 2 diabetics based on World Health Organization criteria \[1\];
• Body mass index (BMI) ≥ 23 kg/m2;
• Have been treated with ≥ 3 kinds of oral hypoglycemic agents (OHAs) with persistent (\> 6 months) high HbA1c (≥ 7.0 %).

You may not qualify if:

• Type 1 diabetes, gestational diabetes, or other specific types of diabetes;
• Have received insulin therapy in the past three months;
• Have serious gastrointestinal (GI) tract diseases, such as peptic ulcers or GI tract bleeding;
• Experience stressful situations, including diabetic ketoacidosis, nonketotic hyperosmolar diabetic coma, severe infection, or surgery in the previous one month;
• Suffer from hepatic insufficiency with alanine aminotransferase (ALT) 2 times the upper limit of normal or renal insufficiency with estimated glomerular filtration rate (eGFR) \< 60;
• Uncontrolled hypertension (blood pressure ≥ 160/100 mmHg);
• Mental illness, abused or addicted to alcohol, psychoactive substances or other drugs;
• Pregnant, lactating, or plan to become pregnant;
• Hemoglobin disease or chronic anemia;
• Have underlying conditions that could lead to poor compliance;
• History of cerebrovascular disease or myocardial infarction;
• Have undergone Chinese medicine treatment in the past two weeks.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Unknown Facility

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Coptidis rhizoma extract

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. YH Huang
• Organization: Chang Gung Memorial Hospital

igighuang@gmail.com

+886975360240

Study Officials

• Yueh-Hsiang Huang, MD

  Chang Gung Memorial Hospital, Taoyuan, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 27, 2016
• Study Start: June 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2016-03

Locations

TW (1)