This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.
This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control. Screening will be made to select eligible participants before intervention. Patients were randomly assigned to one of two groups(metformin or benaglutide) for therapies for 12 weeks including a two-week dose adjustment period and a 10-week dose stabilization period. Lifestyle interventions will be maintained during the treatment period. Subjects are followed up every 4 weeks for examinations.At the end of the study, data will be collected and analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
2-week dose adjustment period(0-2weeks)\[before meals\] 0-2d: - ;250mg,po; -. 3-4d: - ;250mg,po; 250mg,po. 5-6d: 250mg,po; 250mg,po; 250mg,po. 7-9d: 250mg,po; 500mg,po; 250mg,po. 10-11d: 250mg,po; 500mg,po; 500mg,po. 12-14d: 500mg,po; 500mg,po; 500mg,po. 10-week dose stabilization period(3-12weeks) Metformin Hydrochloride Tablet 500mg tid po.
2-week dose adjustment period(0-2weeks) \[before meals\] 0-2d: -; 0.1mg,iH; -; 3-4d: -; 0.1mg,iH; 0.1mg,iH; 5-6d: 0.1mg,iH; 0.1mg,iH; 0.1mg,iH; 7-9d: 0.1mg,iH; 0.2mg,iH; 0.1mg,iH; 10-11d: 0.1mg,iH; 0.2mg,iH; 0.2mg,iH; 12-14d: 0.2mg,iH; 0.2mg,iH; 0.2mg,iH. 10-week dose stabilization period(3-12weeks) Benaglutide Injection 0.2mg,100ul,tid,iH
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
RECRUITINGChanges in body weight
Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention.
Time frame: Change from Baseline after 12 weeks treatment
Changes in body mass index (BMI) of subjects
All 30 subjects of each group would be evaluted by changes in body mass index (BMI) after 12 weeks treatment
Time frame: Change from Baseline after 12 weeks treatment
Changes in Body Fat Levels
Changes in Body Fat Levels from Baseline: Body Composition Analysis
Time frame: Change from Baseline after 12 weeks treatment
Changes in blood lipid levels
The changes in blood lipid levels such as cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein will be measured at the beginning and the end.
Time frame: Change from Baseline after 12 weeks treatment
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