This study is a multi-center, open label, randomized controlled trial that main purpose of this study is to evaluate the differences of glucose control and weight loss between Beinaglutide and Dulaglutide in type 2 diabetes with overweight or or Obesity.
About 2/3 of patients with type 2 diabetes are overweight or obese in China, several studies had confirmed that overweight and obesity could cause type 2 diabetes. GLP-1 receptor agonist could control diabetes meanwhile loss the patient weight. This is a multi-center, openlabel, 1:1 randomized controlled trial to investigate the differences of glucose control and weight loss between two GLP-1 receptor agonist, Beinaglutide and Dulaglutide, in type 2 diabetes with overweight or Obesity. The study comprises the 0-2 weeks of screening period and the 16-week intervention period. 120 patients according to the inclusion/exclusion criteria would recruit from 4 sites in China, then the participant will be randomized to three times a day of subcutaneous beinaglutide(dose escalate to 0.2mg), or once-weekly of 1.5mg subcutaneous dulaglutide for 16-week. The primary endpoint is the change from baseline to week 16 in HbA1c. The second endpoint is the change from baseline to week 16 in weight.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Patients received beinaglutide subcutaneously three times a day for 16 weeks, the dose of beinaglutide escalate from 0.06mg to 0.2mg per 3-7 days according to subject's specific situation.
Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
RECRUITINGThe First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
haemoglobin A1c(HbA1c)
Absolute changes from baseline in HbA1c at week 16.
Time frame: From baseline to 16 week.
Weight loss
The proportion of weight loss from baseline to week 16;the proportion of subjects who loss 5% weight at week 16 compares baseline.
Time frame: From baseline to 16 week.
GLucose
Absolute changes from baseline in fasting glucose and postprandial glucose at week 16.
Time frame: From baseline to 16 week.
Body Mass Index(BMI)
Absolute changes from baseline in BMI in at week 16, body mass index (BMI) was calculated as the body weight (kg)/height (m)2.
Time frame: From baseline to 16 week.
Waistline
Absolute changes from baseline in waistline at week 16.
Time frame: From baseline to 16 week.
Hipline
Absolute changes from baseline in hipline at week 16.
Time frame: From baseline to 16 week.
Serum total cholesterol
Absolute changes from baseline in serum total cholesterol at week 16.
Time frame: From baseline to 16 week.
Serum triglycerides
Absolute changes from baseline in triglycerides at week 16.
Time frame: From baseline to 16 week.
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The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGSerum Low Density Lipoprotein-Cholesterol(LDL-C)
Absolute changes from baseline in LDL-C at week 16.
Time frame: From baseline to 16 week.
Serum High Density Lipoprotein-Cholesterol(HDL-C)
Absolute changes from baseline in HDL-C at week 16.
Time frame: From baseline to 16 week.
Adipose tissue of liver
Absolute changes from baseline in HDL-C at week 16, adipose tissue of liver will be mersured by Fibroscan, a device useing an ultrasound transducer probe to vibrations of liver presenting adipose tissue content.
Time frame: From baseline to 16 week.
Homeostasis model assessment for insulin resistance(HOMA-IR)
Absolute changes from baseline in HOMA-IR at week 16, HOMA-IR was calculated as \[fasting glucose (mmol/L)× fasting insulin (μU/ml)/22.5\].
Time frame: From baseline to 16 week.
Homeostasis model assessment for β cell(HOMA-β)
Absolute changes from baseline in HOMA-β at week 16, HOMA-β was calculated as \[20× fasting insulin (μU/ml)/fasting glucose (mmol/L)-3.5\].
Time frame: From baseline to 16 week.