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.