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Liraglutide injection is a glucagon-like peptide-1 (GLP-1) analogue that activates the cyclic adenosine monophosphate (cAMP) and mitogen-activated protein kinase (MAPK) pathway by binding to the GLP-1 receptor (GLP-1R),thus,it has physiological effects such as glucose-dependent insulin synthesis and secretion, inhibition of β-cell apoptosis, promotion of β-cell proliferation and regeneration, inhibition of glucagon secretion, reduction of food intake, delay of gastric emptying, enhancement of glucose utilization in peripheral tissues and reduction of glycogen output. Liraglutide injection,developed and marketed as Victoza® by Novo Nordisk,is indicated for the treatment of patients with type 2 diabetes and was approved by the U.S. Food and Drug Administration in 2010.This 26-week trial compares the effectivity on glycaemic control,safety and immunogenicity of liraglutide injection and Victoza® in patients with type 2 diabetes inadequately controlled by oral metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQZ2451+metformin hydrochloride | Experimental | TQZ2451 injection (0.6mg qd from baseline to week 1;1.2mg qd during week 2;1.8mg qd from week 3 to week 26) + metformin hydrochloride sustained-release tablets (1500-2000mg qd) |
|
| Victoza®+metformin hydrochloride | Active Comparator | Victoza® (0.6mg qd from baseline to week 1;1.2mg qd during week 2;1.8mg qd from week 3 to week 26) + metformin hydrochloride sustained-release tablets (1500-2000mg qd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Victoza®. | Drug | Patients will receive Victoza®. Both products will be provided as pen-injector. |
|
| Measure | Description | Time Frame |
|---|---|---|
| glycated hemoglobin (HbA1c) | Changes in glycated hemoglobin (HbA1c) relative to baseline. | week 0,week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Changes in body weight relative to baseline. | week 0,week 26 |
| Proportion of achieving HbA1c target (<7.0% or ≤6.5%) | week 0,week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dalong Zhu, doctor | Contact | 025-68182432 | zhudalong@nju.edc.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230000 | China |
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| Metformin Hydrochloride | Drug | Patients who were receiving metformin prior to study will continue to receive it during the study. |
|
| TQZ2451 | Drug | Patients will receive TQZ2451.Both products will be provided as pen-injector. |
|
| HbA1c change from baseline | week 0,week 14 |
| Changes in fasting venous blood glucose (FPG). | week 0,week 14,week 26 |
| Changes in 2h-Postprandial Blood Glucose(2h-PBG). | week 0,week 14,week 26 |
| Changes in fasting insulin. | week 0,week 14,week 26 |
| Changes in fasting C peptide. | week 0,week 14,week 26 |
| Changes in systolic blood pressure. | week 0,week 14,week 26 |
| Changes in diastolic blood pressure. | week 0,week 14,week 26 |
| Number of adverse events and serious adverse events during exposure to trail product. | week 0-26 |
| Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes during exposure to trail product. | week 0-26 |
| Positive rate of liraglutide anti-drug antibody(ADA). | week 0-26 |
| Percentage of participants with clinically significant change from baseline in vital signs. | week 0-26 |
| Percentage of participants with clinically significant change from baseline in laboratory parameters. | week 0-26 |
| The Second People's Hospital of Heifei | Not yet recruiting | Hefei | Anhui | 230000 | China |
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| Ma'anshan People's Hospital | Recruiting | Ma’anshan | Anhui | 243000 | China |
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| Yijishan Hospital of Wannan Medical College | Recruiting | Wuhu | Anhui | 241000 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| The Ninth People's Hospital of Chongqing | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| The Second Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400000 | China |
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| Affiliated Hospital of Guangdong Medical University | Recruiting | Zhanjiang | Guangdong | 524000 | China |
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| Liuzhou People's Hospital | Recruiting | Liuzhou | Guangxi | 545000 | China |
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| The First People's Hospital of Nanning | Recruiting | Nanning | Guangxi | 530000 | China |
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| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550000 | China |
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| The Third Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| The Fourth Affiliated Hospital of Harbin Medical University | Recruiting | Harbin | Heilongjiang | 150000 | China |
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| The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | 471000 | China |
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| Xinxiang Central Hospital | Recruiting | Xinxiang | Henan | 453000 | China |
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| People's Hospital of Zhengzhou | Recruiting | Zhengzhou | Henan | 450000 | China |
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| The Third People's Hospital of Hebei | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| The Second People's Hospital of Lianyungang | Not yet recruiting | Lianyungang | Jiangsu | 222000 | China |
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| Nanjing Drum Tower Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing Jiangning Hospital | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| Xuzhou Third People's Hospital | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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| Nanchang First Hospital | Not yet recruiting | Nanchang | Jiangxi | 330000 | China |
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| Affiliated Hospital of Changchun University of Chinese Medicine | Recruiting | Changchun | Jilin | 130000 | China |
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| Jilin Province FAW General Hospital | Recruiting | Changchun | Jilin | 130000 | China |
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| The Second Hospital of Jilin University | Recruiting | Changchun | Jilin | 130000 | China |
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| Meihekou Central Hospital | Recruiting | Tonghua | Jilin | 134000 | China |
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| Dalian Municipal Central Hospital Affiliated of Dalian Medical University | Not yet recruiting | Dalian | Liangning | 116000 | China |
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| People's Hospital of Ningxia Hui Autonomous Region | Recruiting | Yinchuan | Ningxia | 750000 | China |
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| Jinan Central Hospital | Recruiting | Jinan | Shandong | 250000 | China |
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| Weifang Traditional Chinese Hospital | Not yet recruiting | Weifang | Shandong | 261000 | China |
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| Shanghai Pudong Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Changzhi People's Hospital | Recruiting | Changzhi | Shanxi | 046000 | China |
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| Peace Hospital Affiliated to Changzhi Medical College | Recruiting | Changzhi | Shanxi | 046000 | China |
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| Jincheng General Hospital | Recruiting | Jincheng | Shanxi | 048000 | China |
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| Second Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| Shanxi Provincial People's Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| The First Affiliated Hospital of The Fourth Military Medical University | Not yet recruiting | Xian | Shanxi | 710000 | China |
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| The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital) | Recruiting | Xian | Shanxi | 710000 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong Univesity | Not yet recruiting | Xi’an | Shanxi | 710000 | China |
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| Yuncheng Central Hospital | Recruiting | Yuncheng | Shanxi | 044000 | China |
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| General Hospital of Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Tianjin First Central Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| First Affiliated Hospital of Kunming Medical University | Recruiting | Kunming | Yunnan | 650000 | China |
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| Zhejiang Provincial People's Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Taizhou First People's Hospital | Not yet recruiting | Taizhou | Zhejiang | 318000 | China |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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