Evaluation of the Chinese herbal medicine Jinlida in type 2 diabetes patients based on stratification: Results of subgroup analysis from a 12‐week trial

Abstract Background The C hinese herbal medicine J inlida can significantly enhance the hypoglycemic action of metformin. However, the population showing the best responses to J inlida has not been clarified. The aim of the present study was to compare the efficacy of J inlida in type 2 diabetes mellitus ( T2DM ) after stratification. Methods Data were analyzed from a 12‐week randomized placebo‐controlled double‐blind multicenter study with 192 T2DM patients (186 completed the study). The efficacy evaluation included HbA1c , fasting plasma glucose ( FPG ), and 2‐h postprandial glucose ( 2hPG ) levels stratified by baseline HbA1c , sex, age, body mass index ( BMI ), and duration of T2DM diagnosis. Homeostasis model assessment of insulin resistance ( HOMA‐IR ) and homeostatic model assessment of β‐cell function ( HOMA‐β ) were also evaluated stratified by baseline insulin levels. Results In the J inlida group, HbA1c was significantly reduced ( P < 0.05). Greater reductions were observed in patients with baseline HbA1c >8.5%, in males and in those aged >60 years, with a BMI ≤24 kg/m 2 , or with a duration of T2DM diagnosis >5 years ( P < 0.05). Compared with baseline, J inlida significantly alleviated insulin resistance ( P < 0.05) in patients with baseline insulin levels >20 mU/L. Jinlida also significantly improved β‐cell function in patients with baseline insulin levels ≤20 mU/L ( P < 0.05). Conclusions Jinlida significantly improved glycemic control, with greater improvements in patients with poor glycemic control and male, elderly, of normal weight, or with a long disease course. Furthermore, J inlida alleviated insulin resistance with hyperinsulinemia and promoted insulin secretion with hypoinsulinemia. These results need to be further confirmed in clinical trials.