Evaluation of efficacy and safety
ADVERSE EVENTS, INSULIN RESISTANCE
For evaluation of anti-diabetic activity of CLM, laboratory test for FBG, HbA1c, insulin, and C-peptide were performed at each visit. Oral glucose tolerance test (OGTT) (2-h postprandial glucose test) was performed at the baseline (visits 2) and after 12 weeks (visit 4).HOMA-IR index is the most used method for estimating insulin resistance and was calculated as follows. The product of basal glucose (mg/dL) and fasting insulin (ulU/mL) divided by 22.5. HOMA-IR by C-peptide was analyzed by replacing insulin with C-peptide in HOMA-IR formula. For safety evaluation, vital sign (systolic and diastolic blood pressure, pulse rate), electrocardiogram, laboratory test (complete blood cell count, chemistry laboratory test, urinalysis) and adverse events were thoroughly checked for participants.