Study to Assess the Efficacy and Safety of Liraglutide in the Treatment of Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04373967
• Other study ID #: TQF2451-III-01
• Status: Recruiting
• Phase: Phase 3
• Start date: April 29, 2020
• Est. completion date: December 2, 2021

Study information

• Verified date: July 2020
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Dalong Zhu, doctor
• Phone: 025-68182432
• Email: zhudalong[@]nju.edc.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: December 2, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
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	Changzhi People's Hospital	Changzhi	Shanxi
China	Peace Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Ninth People's Hospital of Chongqing	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Dalian Municipal Central Hospital Affiliated of Dalian Medical University	Dalian	Liangning
China	The Affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
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 Second Hospital of Anhui Medical University	Hefei	Anhui
China	The Second People's Hospital of Heifei	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	Jincheng General Hospital	Jincheng	Shanxi
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Liuzhou People's Hospital	Liuzhou	Guangxi
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Ma'anshan People's Hospital	Ma'anshan	Anhui
China	Nanchang First Hospital	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nanjing Jiangning Hospital	Nanjing	Jiangsu
China	The First People's Hospital of Nanning	Nanning	Guangxi
China	Shanghai Pudong Hospital	Shanghai	Shanghai
China	The Third Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Taizhou First People's Hospital	Taizhou	Zhejiang
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin First Central Hospital	Tianjin	Tianjin
China	Meihekou Central Hospital	Tonghua	Jilin
China	Weifang Traditional Chinese Hospital	Weifang	Shandong
China	The Third People's Hospital of Hebei	Wuhan	Hubei
China	Yijishan Hospital of Wannan Medical College	Wuhu	Anhui
China	The First Affiliated Hospital of Xi'an Jiaotong Univesity	Xi'an	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	Xinxiang Central Hospital	Xinxiang	Henan
China	Xuzhou Third People's Hospital	Xuzhou	Jiangsu
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia
China	Yuncheng Central Hospital	Yuncheng	Shanxi
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin (HbA1c)	Changes in glycated hemoglobin (HbA1c) relative to baseline.	week 0,week 26
Secondary	Body weight	Changes in body weight relative to baseline.	week 0,week 26
Secondary	Proportion of achieving HbA1c target (<7.0% or =6.5%)		week 0,week 26
Secondary	HbA1c change from baseline		week 0,week 14
Secondary	Changes in fasting venous blood glucose (FPG).		week 0,week 14,week 26
Secondary	Changes in 2h-Postprandial Blood Glucose(2h-PBG).		week 0,week 14,week 26
Secondary	Changes in fasting insulin.		week 0,week 14,week 26
Secondary	Changes in fasting C peptide.		week 0,week 14,week 26
Secondary	Changes in systolic blood pressure.		week 0,week 14,week 26
Secondary	Changes in diastolic blood pressure.		week 0,week 14,week 26
Secondary	Number of adverse events and serious adverse events during exposure to trail product.		week 0-26
Secondary	Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes during exposure to trail product.		week 0-26
Secondary	Positive rate of liraglutide anti-drug antibody(ADA).		week 0-26
Secondary	Percentage of participants with clinically significant change from baseline in vital signs.		week 0-26
Secondary	Percentage of participants with clinically significant change from baseline in laboratory parameters.		week 0-26