Clinical Study On Exenatide Treat Obesity And Type2Diabetes Mellitus

Objective: This paper focuses on the effect and safety evaluation of the combinedtherapy of exenatide and aspart30for obese T2DM patients with undesirable bloodglucose control results from metformin-only treatments in the control of blood glucose,improvement of pancreatic beta cell function, alleviation of insulin resistance,improvementof insulin secretion and sensitivity, evaluation and the incidence of adverse events andother aspects of efficacy and safety.Methods: In this study, according to the1999WHO proposed diagnostic criteria ofdiabetes,60cases of obese T2DM outpatients and hospitalized patients from departmentsof endocrinology of the Traditional Chinese Medicine Hospital and other hospitals inZhangjiagang city between June2010and June2012with undesirable blood glucosecontrol results from oral administration of hypoglycemic agents were selected as samplepatients. All patients are in accordance with the following conditions:(1) meet the1999WHO T2DM Diagnosis Standard,(2) with3months’ or above oral administration ofmaximum tolerated dose (1000-1500mg/d) of metformin and undesirable results,(3)FBG≥7.0mmol/L,7.0%≤HbA1C≤11%,(4) obese: BMI≥28.0kg/㎡,(5) willing to sign theFree Prior Informed Consent. Patients were randomly divided into exenatide group (n=30)and insulin aspart30group (n=30). Gender, age, course of disease, BMI and blood glucoselevel are of no significant differences among the60patients. subcutaneous injection of5μgexenatide twice a day were applied to the exenatide group, dosage was increased to10μgafter1month. Subcutaneous injection of insulin aspart30twice a day were applied to theinsulin aspart30group, initial dosages depend on the blood glucose level of patient. Allinjections were applied before meals with dosages adjusted every1or2days. All patientswere receiving injection therapy while maintained the original oral administration ofmetformin. Observing period last for12weeks. Information of patients in both groupsbefore and after therapy were observed and recorded, such as general information (weight, abdominal circumference), blood glucose (FPG、PPG、HbA1c), islet function (FCP、PCP),blood fat (TG、TC、HDL、LDL) and other indicators and also occurrence of adverse drugreaction and low glucose.Patients may terminate his/her participation for intolerance ofadverse drug reaction, incompatible with the therapeutic plan or ineffective result at anytime of the clinical research period.All statistics were analyzed by SPSS16.0with the statistical differences valid when P＜0.05.Results: This research included60samples with2cases of adverse drug reaction and0case of low glucose observed in the exenatide group,5cases of low glucose observed inthe insulin aspart30group. No patients seceded from the research. After12weeks’ oftherapy,(1) Comparison of blood glucose level (satisfied level being FPG<7.0mmol/L,2hPG<10.0mmol/L and HbA1c<7.0%):28cases and21cases reached the satisfiedlevel in exenatide group and the insulin aspart30group, with percentage being93.3%and70%respectively.There are statistical differences between the two groups (P<0.05).(2)Levels of FBG,2hPG and HbA1C shown significant decline in both groups compared tothe baseline with the exenatide group declined more greatly than the insulin aspart30group (P<0.01).(3) Blood fat level: no great changes were observed for levels of TG、LDL、TC、HDL in both groups compared to the baseline level (P>0.05). But TG, LDL, TClevels, exenatide is lower than the insulin treatment group after treatment, and thedifference is statistically significant (P<0.05).(4) Islet function: levels of FCP and PCProse in both groups with exenatide group increased more significantly (P<0.01).(5)Bodyweight, abdominal circumference and BMI: exenatide group was decreased compared withthat before treatment, while insulin group than before treatment increased, and thedifference is statistically significant (P<0.05);(6) Adverse drug reaction: the most commonadverse reaction for patients in both groups was slight to moderate nausea which istolerable to patients, this reaction will disappear after2to3weeks.2cases of severegastrointestinal adverse reaction were observed in exenatide group, insulin treatment groupdid not appear gastrointestinal reaction; exenatide group did not appear low glucosereaction,5cases of low glucose reaction were observed in the insulin aspart30group.(7)Exenatide group insulin resistance and pancreatic beta cell function improvedsignificantly, and before and after the treatment were compared with statistical significance(P<0.05) or (P<0.01). Conclusion: The oral administration of metformin or sulfonylureas, glucose remainspoorly controlled type2diabetic and obese patients, with exenatide or insulin aspart30caneffectively improve blood glucose target rate, decrease HbA1c, but exenatide glycaemiccontrol more stable, low risk of hypoglycemia, and improve the first phase insulinsecretion, improve insulin sensitivity, reduce weight, reduce blood fat, adverse reaction ofgastrointestinal tract with slight, well tolerated, and the use of a fixed dose, simpleoperation, is suitable crowd in clinical application. It is one of the important alternativeoptions for treatment of poor glycemic control in obese patients with type2diabetes.