Study to Assess the Efficacy and Safety of Liraglutide in the Treatment of Type 2 Diabetes
A Phase III,Randomized,Parallel,Open-label,Multicenter Trial to Compare the Efficacy and Safety of Liraglutide and Victoza® in Patients With Type 2 Diabetes Inadequately Controlled by Oral Metformin Alone
1 other identifier
interventional
424
1 country
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes
Started Apr 2020
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2020
CompletedStudy Start
First participant enrolled
April 29, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 2, 2021
CompletedJuly 8, 2020
July 1, 2020
1.6 years
April 28, 2020
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
glycated hemoglobin (HbA1c)
Changes in glycated hemoglobin (HbA1c) relative to baseline.
week 0,week 26
Secondary Outcomes (14)
Body weight
week 0,week 26
Proportion of achieving HbA1c target (<7.0% or ≤6.5%)
week 0,week 26
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
- +9 more secondary outcomes
Study Arms (2)
TQZ2451+metformin hydrochloride
EXPERIMENTALTQZ2451 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 COMPARATORVictoza® (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)
Interventions
Patients will receive Victoza®. Both products will be provided as pen-injector.
Patients who were receiving metformin prior to study will continue to receive it during the study.
Patients will receive TQZ2451.Both products will be provided as pen-injector.
Eligibility Criteria
You may qualify if:
- Diagnosed as type 2 diabetes.
- 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.
You may not qualify if:
- Diagnosed as type 1 or other types of diabetes.
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
The Second People's Hospital of Heifei
Hefei, Anhui, 230000, China
Ma'anshan People's Hospital
Ma’anshan, Anhui, 243000, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, 241000, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
The Ninth People's Hospital of Chongqing
Chongqing, Chongqing Municipality, 400000, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545000, China
The First People's Hospital of Nanning
Nanning, Guangxi, 530000, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
Xinxiang Central Hospital
Xinxiang, Henan, 453000, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000, China
The Third People's Hospital of Hebei
Wuhan, Hubei, 430000, China
The Second People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210000, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, 210000, China
Xuzhou Third People's Hospital
Xuzhou, Jiangsu, 221000, China
Nanchang First Hospital
Nanchang, Jiangxi, 330000, China
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, 130000, China
Jilin Province FAW General Hospital
Changchun, Jilin, 130000, China
The Second Hospital of Jilin University
Changchun, Jilin, 130000, China
Meihekou Central Hospital
Tonghua, Jilin, 134000, China
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liangning, 116000, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750000, China
Jinan Central Hospital
Jinan, Shandong, 250000, China
Weifang Traditional Chinese Hospital
Weifang, Shandong, 261000, China
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 200000, China
Changzhi People's Hospital
Changzhi, Shanxi, 046000, China
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 046000, China
Jincheng General Hospital
Jincheng, Shanxi, 048000, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030000, China
The First Affiliated Hospital of The Fourth Military Medical University
Xian, Shanxi, 710000, China
The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)
Xian, Shanxi, 710000, China
The First Affiliated Hospital of Xi'an Jiaotong Univesity
Xi’an, Shanxi, 710000, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044000, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300000, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300000, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000, China
Taizhou First People's Hospital
Taizhou, Zhejiang, 318000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2020
First Posted
May 5, 2020
Study Start
April 29, 2020
Primary Completion
December 1, 2021
Study Completion
December 2, 2021
Last Updated
July 8, 2020
Record last verified: 2020-07