Study to Assess the Efficacy and Safety of Liraglutide in the Treatment of Type 2 Diabetes
NCT ID: NCT04373967
Last Updated: 2020-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
424 participants
INTERVENTIONAL
2020-04-29
2021-12-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TQZ2451+metformin hydrochloride
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)
Metformin Hydrochloride
Patients who were receiving metformin prior to study will continue to receive it during the study.
TQZ2451
Patients will receive TQZ2451.Both products will be provided as pen-injector.
Victoza®+metformin hydrochloride
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)
Victoza®.
Patients will receive Victoza®. Both products will be provided as pen-injector.
Metformin Hydrochloride
Patients who were receiving metformin prior to study will continue to receive it during the study.
Interventions
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Victoza®.
Patients will receive Victoza®. Both products will be provided as pen-injector.
Metformin Hydrochloride
Patients who were receiving metformin prior to study will continue to receive it during the study.
TQZ2451
Patients will receive TQZ2451.Both products will be provided as pen-injector.
Eligibility Criteria
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Inclusion Criteria
* Stably daily dose of metformin alone\[between the dose of 1500mg and 2000mg inclusive\] for at least 12 weeks prior to day of screening .
* HbA1c(glycosylated haemoglobin) of 7-11%(both inclusive).
* Body mass index (BMI) of 18.5-45 kg/m2(both inclusive).
* The patient must give informed consent to the study before the trial and voluntarily sign the informed consent form.
* The patient can communicate well with the researcher and complete the study in accordance with the research regulations.
Exclusion Criteria
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist, dipeptidyl peptidase-4 (DPP-4) inhibitor and insulin treatment within 3 months before screening.\[short term (cumulative use ≤7 days) insulin therapy due to intermittent disease is excluded\]
* Treatment with systemic glucocorticoid therapy within 3 months before screening\[topical medication or inhaled product is excluded\] .
* Treatment with Chinese medicine preparations having hypoglycemic effects within 1 month before screening.
* Patients with recurrent severe or unconscious hypoglycemia within 3 months before screening.
* Patients with acute metabolic complications (ketoacidosis, lactic acidosis or hypertonic coma, etc.) within 6 months before screening.
* History of chronic pancreatitis or idiopathic acute pancreatitis, or suffering from acute or chronic pancreatitis during screening, or blood amylase ≥ 3 times of the upper limit of normal value, or triglycerides ≥ 8.0 mmol / L.
* Fasting blood-glucose(FBG)≥15.0 mmol / L on the day of screening.
* Personal or family history of medullary thyroid carcinoma (MTC) or type 2 multiple endocrine adenoma (MEN2).
* Patients with obvious liver and kidney dysfunction (alanine aminotransferase (ALT)\> 2.5 × upper normal value (ULN), aspartate aminotransferase (AST)\> 2.5 ULN, glomerular filtration rate \<60 Milliliter(mL) / min / 1.73m2
* Hemoglobin \<lower limit of normal value.
* Hyperthyroidism is being treated or the dosage of hypothyroidism is not stable within 6 months.
* Uncontrolled or poorly treated hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg).
* Patients with decompensated heart failure (NYHA grades III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or vascular reconstruction performed (including coronary artery bypass grafting or percutaneous coronary intervention) within 6 months before screening.
* Proliferative retinopathy or macular disease (macular edema) that requires urgent treatment.
* Malignant tumors (except basal cell carcinoma or phosphorous cell skin cancer) diagnosed within the past 5 years.
* Patients with severe chronic gastrointestinal disease (such as active peptic ulcer) and severe infections.
* People who are allergic to any of the ingredients in metformin, liraglutide injection and Victoza®.
* Participated in any other clinical trials within 3 months before screening.
* Pregnant women, lactating women and women of reproductive age who did not take appropriate contraception (sterilization, intrauterine devices, oral contraceptives or barrier contraception) during the trial.
* History of psychotropic substance abuse, alcohol abuse or drug addiction.
* Patients judged as unsuitable participants of the trial by researchers or with poor compliance.
* According to the investigators' judgment, there are seriously concomitant diseases endanger the safety of the patient or prevent the patient from completing the study.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Hospital of Anhui Medical University
Hefei, Anhui, China
The Second People's Hospital of Heifei
Hefei, Anhui, China
Ma'anshan People's Hospital
Ma’anshan, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Ninth People's Hospital of Chongqing
Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
The First People's Hospital of Nanning
Nanning, Guangxi, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Xinxiang Central Hospital
Xinxiang, Henan, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
The Third People's Hospital of Hebei
Wuhan, Hubei, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
Xuzhou Third People's Hospital
Xuzhou, Jiangsu, China
Nanchang First Hospital
Nanchang, Jiangxi, China
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, China
Jilin Province FAW General Hospital
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
Meihekou Central Hospital
Tonghua, Jilin, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liangning, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
Jinan Central Hospital
Jinan, Shandong, China
Weifang Traditional Chinese Hospital
Weifang, Shandong, China
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Jincheng General Hospital
Jincheng, Shanxi, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China
The First Affiliated Hospital of The Fourth Military Medical University
Xian, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
Xian, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong Univesity
Xi’an, Shanxi, China
Yuncheng Central Hospital
Yuncheng, Shanxi, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Taizhou First People's Hospital
Taizhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Tianrong Pan, Master
Role: primary
Jun Ye, Bachelor
Role: primary
Weihong Chen, Bachelor
Role: primary
Jialin Gao, Doctor
Role: primary
Rong Li, Doctor
Role: primary
Xingrong Tan, Master
Role: primary
Min Long, Master
Role: primary
Fuzhen Liu, Master
Role: primary
Yulan Li, Master
Role: primary
Yuanyuan Lin, Master
Role: primary
Ying Hu, Master
Role: primary
Yukun Li, Doctor
Role: primary
Zhifeng Cheng, Doctor
Role: primary
Guoqing Ma, Doctor
Role: primary
Liujun Fu, Master
Role: primary
Xiuqin Geng, Master
Role: primary
Qijuan Dong, Bachelor
Role: primary
Juping Hu, Bachelor
Role: primary
Yunming Gao, Bachelor
Role: primary
Kun Wang, Doctor
Role: primary
Chunrong Xu, Master
Role: primary
Ling Hu, Bachelor
Role: primary
Xiuge Wang, Doctor
Role: primary
Chengwei Song, Master
Role: primary
Yanjun Wang, Doctor
Role: primary
Hongwei Jin, Master
Role: primary
Zhengnan Gao, Master
Role: primary
Hongmei Li, Doctor
Role: primary
Xiaolin Dong, Doctor
Role: primary
Jie Zhang, Master
Role: primary
Dongxiang Xu, Bachelor
Role: primary
Wenhua Zhao, Master
Role: primary
Huwei Shen, Bachelor
Role: primary
Lili Zhang, Master
Role: primary
Xing Li, Doctor
Role: primary
Yanlan Yang, Bachelor
Role: primary
Xiaomiao Li
Role: primary
Jing Xu, Master
Role: primary
Hui Guo, Doctor
Role: primary
Ping Li, Bachelor
Role: primary
Ming Liu, Master
Role: primary
Xia Jiang, Bachelor
Role: primary
Yushan Xu, Doctor
Role: primary
Xiaohong Wu, Doctor
Role: primary
Lijun Wang, Bachelor
Role: primary
Other Identifiers
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TQF2451-III-01
Identifier Type: -
Identifier Source: org_study_id
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