Study On The Effects Of Three Combination Therapy For Newly Diagnosed T2DM Patient

Objective:To Compare efficacy and safety of three combination therapies?saxagliptin with acarbose,saxagliptin with gliclazide modified release,and saxagliptin with metformin?in drug na?ve patients with type 2 diabetes mellitus.Methods:132 newly diagnosed type 2 diabetes mellitus patients were enrolled with high level HbA1c?HbA1c?8.0%and?11.0%?in Nanjing First Hospital,Jiangsu Province Hospital,Zhongda Hospital Southeast University,Nanjing Drum Tower Hospital,the First Affiliated Hospital of Anhui Medical University,the Second Affiliated Hospital of Anhui Medical University from April2015 to May 2017.They were randomly allocated according to 1:1:1 ratio and divided into saxagliptin with acarbose group?group A?,saxagliptin with gliclazide modified release group?group B?,and saxagliptin with metformin group?group C?.5 mg saxagliptin was used as basic therapy in all groups.The patients have experienced 24 weeks'treatment period.During the period,drug dose titration was in 1-4 weeks and 5-24 weeks was for the stable treatment.There were twice follow-ups at 12^th and 24^th weeks.The observation indexes included blood HbA1c,FBG,2h PBG,TC,TG,HDL-C,LDL-C,weight levels,and adverse event,to compare the efficacy and safety of three groups.Results:After 24 weeks'treatment,the HbA1c levels were significantly decreased in all three groups with 2.66�1.21?%??2.88�0.80?%??3.00�1.20?%?,respectively.Among three groups,the patients in the group C showed the best efficacy.Therefore,the efficacy of saxagliptin with metformin was better than saxagliptin with acarbose and saxagliptin with gliclazide modified release.If setting HbA1c<7.0%as the standard HbA1c level,the control rates of group A,B,C were 60.47%,84.09%,93.33%,respectively.If setting HbA1c level?6.5%as the standard HbA1c level,the control rates of group A,B,C were 51.16%,68.18%,80.00%,respectively.Among three groups,the group C showed the best efficacy.After 24 weeks'treatment,the FBG levels were significantly decreased in all three groups,respectively reduced 2.71?0.71,3.62?mmol/L,2.98?2.12,4.11?mmol/L,2.35?1.63,4.05?mmol/L,respectively.2h PBG levels in all three groups were significantly reduced with 6.63?3.56,9.38?mmol/L,5.80?3.25,7.05?mmol/L,8.08?4.94,9.45?mmol/L,respectively.No group raised the fasting lipid levels significantly.The treatment method with saxagliptin with metformin and saxagliptin with acarbose reduced weight,however,the treatment method with saxagliptin with gliclazide modified release increased weight.For safety concerns,the difference of incidence rate for hypoglycemia and adverse reaction was not significant?p>0.05?.Conclusion:In the present study for newly diagnosed type 2 diabetes mellitus population with high level HbA1c?HbA1c?8.0%and?11.0%?,all three groups could control blood glucose efficiently with no adverse effects.More than 60%patients reached the standard HbA1c?<7.0%?,especially for saxagliptin with metformin,which can reduce the HbA1c levels by 3.00�1.20?%?for newly diagnosed type 2 diabetes mellitus patient and the control rate of HbA1c up to 93.33%.The present study reconfirmed the synergy between saxagliptin and metformin,which could be an ideal choice to use saxagliptin based combination therapy in the early phase for newly diagnosed type 2 diabetes mellitus patient with high HbA1c levels.