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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2021
  • participants needed
    424
  • sponsor
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Updated on 25 January 2021
Investigator
Dalong Zhu, doctor
Primary Contact
The Fourth Affiliated Hospital of Harbin Medical University (0.0 mi away) Contact
+45 other location
insulin
body mass index
metformin
glucagon
hemoglobin a1c
liraglutide
glucagon-like peptide-1
glucagon-like peptide 1

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 -cell apoptosis, promotion of -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.

Details
Condition NIDDM, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Metformin Hydrochloride, Victoza®., TQZ2451
Clinical Study IdentifierNCT04373967
SponsorChia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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