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Type 2 DiabetesPhase 3NCT04373967

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

A Phase 3 study testing Victoza®., Metformin Hydrochloride and TQZ2451 in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 46 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Victoza®., Metformin Hydrochloride and TQZ2451
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
46 sitesChina
Study dates
29 Apr 2020to 2 Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.

Trial locations and contacts

46 sites in 1 country.

Dalong Zhu, doctor contact

025-68182432

zhudalong@nju.edc.cn

46 sites in 1 country

China46 sites, 46 recruiting

  • Affiliated Hospital of Changchun University of Chinese Medicine

    Changchun, Jilin, 130000

    Xiuge Wang, Doctor

    Recruiting

  • Jilin Province FAW General Hospital

    Changchun, Jilin, 130000

    Chengwei Song, Master

    Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

    Yanjun Wang, Doctor

    Recruiting

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000

    Wenhua Zhao, Master

    Recruiting

  • Peace Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 046000

    Huwei Shen, Bachelor

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Rong Li, Doctor

    Recruiting

  • The Ninth People's Hospital of Chongqing

    Chongqing, Chongqing Municipality, 400000

    Xingrong Tan, Master

    Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400000

    Min Long, Master

    Recruiting

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liangning, 116000

    Zhengnan Gao, Master

    Not yet recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

    Ying Hu, Master

    Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310000

    Xiaohong Wu, Doctor

    Not yet recruiting

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150000

    Zhifeng Cheng, Doctor

    Recruiting

  • The Second Affiliated Hospital of Heilongjiang University of Chinese Medicine

    Harbin, Heilongjiang, 150000

    Guoqing Ma, Doctor

    Not yet recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230000

    Tianrong Pan, Master

    Not yet recruiting

  • The Second People's Hospital of Heifei

    Hefei, Anhui, 230000

    Jun Ye, Bachelor

    Not yet recruiting

  • Jinan Central Hospital

    Jinan, Shandong, 250000

    Xiaolin Dong, Doctor

    Recruiting

  • Jincheng General Hospital

    Jincheng, Shanxi, 048000

    Lili Zhang, Master

    Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

    Yushan Xu, Doctor

    Recruiting

  • The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222000

    Yunming Gao, Bachelor

    Not yet recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545000

    Yulan Li, Master

    Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

    Liujun Fu, Master

    Recruiting

  • Ma'anshan People's Hospital

    Ma’anshan, Anhui, 243000

    Weihong Chen, Bachelor

    Recruiting

  • Nanchang First Hospital

    Nanchang, Jiangxi, 330000

    Ling Hu, Bachelor

    Not yet recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210000

    Dalong Zhu, Doctor, 025-68182432, zhudalong@nju.edc.cn

    Recruiting

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu, 210000

    Kun Wang, Doctor

    Recruiting

  • The First People's Hospital of Nanning

    Nanning, Guangxi, 530000

    Yuanyuan Lin, Master

    Recruiting

  • Shanghai Pudong Hospital

    Shanghai, Shanghai Municipality, 200000

    Dongxiang Xu, Bachelor

    Recruiting

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Yukun Li, Doctor

    Recruiting

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030000

    Xing Li, Doctor

    Recruiting

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

    Yanlan Yang, Bachelor

    Recruiting

  • Taizhou First People's Hospital

    Taizhou, Zhejiang, 318000

    Lijun Wang, Bachelor

    Not yet recruiting

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300000

    Ming Liu, Master

    Recruiting

  • Tianjin First Central Hospital

    Tianjin, Tianjin Municipality, 300000

    Xia Jiang, Bachelor

    Not yet recruiting

  • Meihekou Central Hospital

    Tonghua, Jilin, 134000

    Hongwei Jin, Master

    Recruiting

  • Weifang Traditional Chinese Hospital

    Weifang, Shandong, 261000

    Jie Zhang, Master

    Not yet recruiting

  • The Third People's Hospital of Hebei

    Wuhan, Hubei, 430000

    Juping Hu, Bachelor

    Not yet recruiting

  • Yijishan Hospital of Wannan Medical College

    Wuhu, Anhui, 241000

    Jialin Gao, Doctor

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong Univesity

    Xi’an, Shanxi, 710000

    Hui Guo, Doctor

    Not yet recruiting

  • The First Affiliated Hospital of The Fourth Military Medical University

    Xian, Shanxi, 710000

    Xiaomiao Li

    Not yet recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)

    Xian, Shanxi, 710000

    Jing Xu, Master

    Recruiting

  • Xinxiang Central Hospital

    Xinxiang, Henan, 453000

    Xiuqin Geng, Master

    Recruiting

  • Xuzhou Third People's Hospital

    Xuzhou, Jiangsu, 221000

    Chunrong Xu, Master

    Recruiting

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750000

    Hongmei Li, Doctor

    Recruiting

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044000

    Ping Li, Bachelor

    Recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524000

    Fuzhen Liu, Master

    Recruiting

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

    Qijuan Dong, Bachelor

    Recruiting

Other trials in China

About this study

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

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.

Conditions
Type 2 Diabetes
Being tested
Victoza®., Metformin Hydrochloride, TQZ2451
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Victoza®.Drug

    Patients will receive Victoza®. Both products will be provided as pen-injector.

  • Metformin HydrochlorideDrug

    Patients who were receiving metformin prior to study will continue to receive it during the study.

  • TQZ2451Drug

    Patients will receive TQZ2451.Both products will be provided as pen-injector.

Study groups in NCT04373967
Study groupRoleWhat they receive
TQZ2451+metformin hydrochlorideExperimentalTQZ2451 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)
Receives: Drug: Metformin Hydrochloride; Drug: TQZ2451
Victoza®+metformin hydrochlorideActive 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)
Receives: Drug: Victoza®.; Drug: Metformin Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. glycated hemoglobin (HbA1c)

    Changes in glycated hemoglobin (HbA1c) relative to baseline.

    Measured: week 0,week 26

Secondary outcomes (14)

  1. Body weight

    Changes in body weight relative to baseline.

    Measured: week 0,week 26

  2. Proportion of achieving HbA1c target (<7.0% or ≤6.5%)

    Measured: week 0,week 26

  3. HbA1c change from baseline

    Measured: week 0,week 14

  4. Changes in fasting venous blood glucose (FPG).

    Measured: week 0,week 14,week 26

  5. Changes in 2h-Postprandial Blood Glucose(2h-PBG).

    Measured: week 0,week 14,week 26

  6. Changes in fasting insulin.

    Measured: week 0,week 14,week 26

  7. Changes in fasting C peptide.

    Measured: week 0,week 14,week 26

  8. Changes in systolic blood pressure.

    Measured: week 0,week 14,week 26

  9. Changes in diastolic blood pressure.

    Measured: week 0,week 14,week 26

  10. Number of adverse events and serious adverse events during exposure to trail product.

    Measured: week 0-26

  11. Number of treatment-emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes during exposure to trail product.

    Measured: week 0-26

  12. Positive rate of liraglutide anti-drug antibody(ADA).

    Measured: week 0-26

  13. Percentage of participants with clinically significant change from baseline in vital signs.

    Measured: week 0-26

  14. Percentage of participants with clinically significant change from baseline in laboratory parameters.

    Measured: week 0-26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start29 Apr 2020
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion2 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
424 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373967
Sponsor's protocol ID
TQF2451-III-01
Status last verified
Jul 2020
First submitted
28 Apr 2020
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Victoza®., Metformin Hydrochloride and TQZ2451 in people with Type 2 Diabetes, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 46 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dalong Zhu, doctor (025-68182432, zhudalong@nju.edc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

glycated hemoglobin (HbA1c) (time frame: week 0,week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04373967.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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