Phase 3
N=46
YH1 in Poorly Controlled Type 2 Diabetes
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02752880 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: The Percentage Change in HbA1c Level From Baseline to 12 Weeks — -11.1; 0.0 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- YH1 group (Drug); placebo group (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Chang Gung Memorial Hospital
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage Change in HbA1c Level From Baseline to 12 Weeks |
-11.1; 0.0 | — |
| SECONDARY The Percentage Change in 2hPG From Baseline to Week 12 |
-26.2; 5.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 20-75 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 %).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02752880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.