Efficacy And Safety Of Exenatide Versus Novomix30for Patients With Type2Diabetes Who Did Not Have Adequate Glycemic Control With Metformin

Objective: To investigate the efficacy and safety of the human GLP-1analogue exenatide versus the human insulin analogue novomix30, as adjunct treat-ments to metformin, in individuals with type2diabetes who did not achieve adequate glycaemic control with metformin alone. Methods:In this26-week randomized, open-label, parallel-group trial participan--ts (aged25-73years, HbAlc7.0-11.0%, BMI<40kg/m2) with type2diabetes who had inadequate glycaemic control on metformin were allocated to receive26weeks’ treatment with subcutaneous exenatide twice daily (n=68), or subcutaneous novnmix30twice or third daily (n=79). The primary endpoint was change in HbA(1c) from baseline to week26. The t and χ2test was used in the data analysis. Results: Compared to the baseline, the same lowering of mean FBG was achieved with exenatide (5.64±1.13) and BIAsp30(6.93±1.06); The great lowering of mean the average PBG was achieved with exenatide (6.9±2.74) than with BIAsp30(8.79±2.56),(P<0.05). The proportion of patients which HbAlc less7.0%was49.4%(exenatide group) and35.5%(BIAsp30),(P<0.05). Compare to the BIAsp30, the greater highering of normal proportion of BMI (76.5%), serum lipids (83.6%), cardiovascular risk factors (79%), urinary albumin (76.5%), and the less fluctuations of blood-glucose (1.17vs1.63) in the exenatide group. Nausea was more common with exenatide (21[31%] patients) than with BIAsp30(1[1%]). Hypog-lycaemia was recorded in about8%of participants in BIAsp30group. Conclusions:Exenatide was superior to BIAsp30for reduction of PBG、HbA(lc), and was well tolerated with minimum risk of hypoglycaemia. At the same time, exenatid may offer more than glycaemic control alone.