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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beinaglutide | Experimental |
| |
| Dulaglutide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beinaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| haemoglobin A1c(HbA1c) | Absolute changes from baseline in HbA1c at week 16. | From baseline to 16 week. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 16 week. |
| GLucose | Absolute changes from baseline in fasting glucose and postprandial glucose at week 16. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiguang Zhou, MD/PhD | Contact | 86-731-85292154 | zhouzg@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China | ||
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| Dulaglutide | Drug | Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks. |
|
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| 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. | From baseline to 16 week. |
| Waistline | Absolute changes from baseline in waistline at week 16. | From baseline to 16 week. |
| Hipline | Absolute changes from baseline in hipline at week 16. | From baseline to 16 week. |
| Serum total cholesterol | Absolute changes from baseline in serum total cholesterol at week 16. | From baseline to 16 week. |
| Serum triglycerides | Absolute changes from baseline in triglycerides at week 16. | From baseline to 16 week. |
| Serum Low Density Lipoprotein-Cholesterol(LDL-C) | Absolute changes from baseline in LDL-C at week 16. | From baseline to 16 week. |
| Serum High Density Lipoprotein-Cholesterol(HDL-C) | Absolute changes from baseline in HDL-C at week 16. | 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. | 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]. | 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]. | From baseline to 16 week. |
| The First Affiliated Hospital of Harbin Medical University |
| Recruiting |
| Harbin |
| Heilongjiang |
| China |
| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C061970 | glucagon-like peptide 1 (7-36) |
| C555680 | dulaglutide |
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