The Comparison Of Glycemic Control And Safety Of DPP-4 Inhibitor And Sulfonylureas In Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Objective:This study aims to analyze the glycemic control and safety of DPP-4 inhibitor and sulfonylureas in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy and provide clinical medicine evidence for Chinese population when choosing drugs.Methods:From January 2015 to September 2016,eleven hospitals recruited 382 patients with confirmed type 2 diabetes mellitus who are aged between 25 to 75 years old,have BMI between 20 to 30kg/m2,HbA1c between 7.0 to 9.0%and have already used metformin at least 1500mg/d for eight weeks.382 patients met the criteria were randomized by computer as 1:1 to either Saxagliptin group or Glimepiride group.Patients in Saxagliptin group took metformin 1500mg and Saxagliptin 5mg dairy while patients in Glimepiride group took metformin 1500mg and glimepiride 1-6 mg daily(the dose should be adjusted by fast blood glucose)until the end of 48 weeks.Baseline was defined as the first day given second line drug.Personal visit would be conducted every 4 weeks until the end of 48 weeks for any patient.The blood and urine samples were collected and analyzed from baseline and every personal visit was conducted according to the study protocol,so as other life measurements.The primary endpoint was comparing the proportion of subjects after 48-week treatment achieving HbA1c<7.0%,with no hypoglycemia(plasma glucose<3.9 mmol/L with or without symptoms)and no body weight gain(weight gain<3.0%).Results:More patients in Saxagliptin group achieved the primary endpoint(46.2%vs.29.8%,X2=8.054,P<0.05)after 48-weeks treatment.There is no statistical difference between two groups in reducing HbAlc.Although Glimepiride group reduced more fast plasma glucose than Saxagliptin group(0.9mmol/L vs.1.4mmol/L,t=2.113,P<0.05),it also experienced higher rate of hypoglycemia events which was six times than Saxagliptin group.When Saxagliptin used with metformin,it shows a phenomenon of weight loss,0.8kg on average.On the contrary,the Glimepiride group witnessed 0.9kg weight gain on average and the difference on weight between two groups reached 1.7kg at 48th week.There was no difference on adverse events or serious adverse events.No drug-related adverse event was found.Conclusions:In Chinese type 2 diabetes patients whose glucose are inadequately controlled with metformin monotherapy,Saxagliptin can reduce HbAlc as much as Glimepiride with less hypoglycemia events and weight loss.It shows a stable and effective glucose control and safety.