Fenugreek Total Saponin Combined Metformin / Sulfonylurea Treatment Of Secondary Failure Type 2 Diabetes In Clinical Research,

ObjectiveBy the means of clinical research trial which is randomized, double-blind, dummy at equal pace comparison., to evaluate the curative effective and safety of trigonella foenum-graecum total saponins in combination with biguanide or sulfaurea drugs in the treatment of patients with type 2 diabetes mellitus which could not be well controlled by biguanide or sulfaurea drugs alone.MethodsA randomized, double-blind, dummy at equal pace comparison and multicentric controlled clinical research trial was carried out. According to the trial conceptual design, 480 T2DM patients whose blood glucose levels were not well controlled by biguanide or sulfaurea drugs alone were randomly divided into the treatment group and the control group in 7 trial centers. Biguanides kind and Sulphanylureas kind were both included 240 examples, each kind was divided to 160 examples in treatment group and 80 examples in control group. Two kinds subjects orally taking drugs not exchanged. on the foundation: treatment group added TFGs capsule which essential component was trigonella foenum-graecum L.total saponins 6 granule per os third; the controll group added TFGs capsule placebo 6 granule per os third. The treatment time was 12weeks.The observation index included safety observation and therapeutic efficiency observation. The therapeutic efficiency observation contained:(1)Writing down the corresponding mainly clinical symptoms and physical signs.(2) main indexs:â‘ fasting blood glucose.â‘¡glycosylated hemoglobin(3) secondary indexs:â‘ postprandial blood sugar.â‘¡body mass index.The safety observation contained:(1) medical examination.(2) the blood-routine, the urine-routine, the stool-routine.(3) electrocardiogram, liver function, kidney function.(4) kak- incident: any time to record.To carry out the statistical analysis after the observation.Results Unite biguanides : the treatment group had better results of fasting blood glucose, glycosylated hemoglobin and postprandial blood glucose than the controll group, the comparison between two groups had significant difference. The change of traditional Chinese medicine syndrome integral: the result hint two sets both could improve traditional Chinese medicine symptoms, the treatment group had better results than the controll group. The change of body mass index: the comparison between two groups had not significant difference, the result hint two sets both didn't have the curative effect in cutting down body mass index. the comparison of DM curative effect: through statistics analysis, the treatment group's excellence rate was 20.5%, effective power was50.0%, ineffective rate was 29.5%, con- effective power was 70.5. the controll group's excellence rate was 9.0%, effective power was48.7%, ineffective rate was 42.3%, con- effective power was 57.7%. the comparison between two groups had significant difference, the treatment group had better results.Unite sulphanylureas: the treatment group had better results of fasting blood glucose, glycosylated hemoglobin and postprandial blood glucose than the controll group, the comparison between two groups had significant difference. The change of traditional Chinese medicine syndrome integral: the result hint two sets both could improve traditional Chinese medicine symptoms, the treatment group had better results than the controll group. The change of body mass index: the comparison between two groups had not significant difference, the result hint two sets both didn't have the curative effect in cutting down body mass index. the comparison of DM curative effect: through statistics analysis, the treatment group's excellence rate was 47.1%, effective power was43.9%, ineffective rate was8.9%, con- effective power was 91.1. the controll group's excellence rate was 17.3%, effective power was62.7%, ineffective rate was 20.0%, con- effective power was 80.0% the comparison between two groups had significant difference, the treatment group had better results.Both biguanides kind and sulphanylureas kind didn't appeared any adverse effect.ConclusionTrigonella foenum-graecum total saponins had a costant effect on type 2 diabetes mellitus in clinical practice: it could relieve the symptoms and improve physical signs and the related indexs of type 2 diabetes mellitus patients. It was a kind of safe medicine. It could degrade the blood-fasting sugar; glycosylated hemoglobin and postprandial blood glucose significantly. It could educe the preponderance of traditional Chinese medicine and be worth generalizing to clinicaluse.