Type 2 diabetes
Conditions
Interventions
Experimental group:MWN101 Injection
Control group:Placebo/Semaglutide
Sponsors
Beijing Friendship Hospital Pinggu Campus,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.(Medical History) Chinese adult patients with type 2 diabetes mellitus aged between 18 and 75 years (inclusive of 18 and 75 years) who meet the diagnostic criteria of the 'Chinese Guidelines for Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition)'. Each dosage group should include both male and female participants, and meet any of the following criteria: (1) Newly diagnosed type 2 diabetes patients who have received at least 8 weeks of dietary and exercise intervention and have never taken anti-diabetic drugs before; or (2) Previously diagnosed type 2 diabetes patients currently in a dietary and exercise intervention phase, who have not received diabetes medication treatment within 8 weeks prior to screening, and according to the investigator's assessment of their condition, can add experimental drug treatment on the basis of lifestyle intervention. 2. (Examination) Body Mass Index (BMI) at screening: 23.0 kg/m^2<= BMI <= 40.0 kg/m^2. 3. (Examination) Glycated Hemoglobin (HbA1c) test results at screening/baseline: 7.0% <=HbA1c <= 10.5%. 4. (Examination) Fasting Plasma Glucose (FPG) at screening/baseline: FPG <= 13.3 mmol/L (if there are special factors affecting blood glucose, a retest can be performed within 1 week). 5.(Medical History) No pregnancy plan within 3 months after signing the informed consent and until the end of the study, and voluntarily take effective contraceptive measures to avoid pregnancy or causing the partner to become pregnant, with no plans for sperm or egg donation. 6. (Medical History) Fully understand the purpose, nature, methods of the trial, and possible adverse reactions, able to complete the trial according to the protocol requirements, voluntarily participate as a subject, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.(Medical history and examination) Diagnosed with non-type 2 diabetes mellitus: such as type 1 diabetes mellitus, special types of diabetes mellitus (e.g., genetic defects in beta-cell function, genetic defects in insulin action, exocrine pancreatic diseases, etc.); 2.(Medical history) Experienced severe acute diabetic complications within 12 months prior to screening, such as diabetic ketoacidosis, hyperosmolar hyperglycemia, lactic acidosis, etc.; 3.(Medical history and examination) Presence of severe chronic diabetic complications at screening, such as diabetic nephropathy, proliferative retinopathy; peripheral vascular disease leading to amputation, chronic foot ulcers, or intermittent claudication; painful diabetic neuropathy, etc.; 4. (Medical history) History of other severe endocrine system diseases affecting glucose metabolism, such as multiple endocrine adenomas, acromegaly, Cushing's syndrome; 5. (Medical history) Experienced grade 3 hypoglycemia within 6 months prior to screening (see Appendix 3); 6.(Medical history and examination) Occurrence of the following cardiovascular diseases within 6 months prior to screening: heart failure (NYHA class III-IV), myocardial infarction, history of coronary artery bypass graft surgery or coronary stent implantation, treatable severe arrhythmias such as second- or third-degree atrioventricular block, long QT syndrome, or prolonged QTc interval (QTcF female >=470ms or male >=450ms); 7.(Medical history) Suffered from hemorrhagic or ischemic stroke, transient ischemic attack within 6 months prior to screening, assessed by the investigator as unsuitable for participation in this clinical trial; 8.(Medical history) Suffered from severe trauma or severe infection that may affect blood glucose control, or undergone major surgery within 3 months prior to screening; 9.(Examination) Presence of thyroid dysfunction not controlled by a stable drug dose at screening, or clinically significant abnormal thyroid function test results requiring initiation of treatment at screening; 10. (Examination) Uncontrolled hypertension after treatment at screening (systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg) or subjects whose untreated blood pressure meets the above criteria; 11.(Medical history) History of acute or chronic pancreatitis or clinical evidence thereof; 12. (Medical history) History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2; 13. (Medical history and examination) History of hematological diseases or history that may affect HbA1c test results or increase subject risk: (e.g., aplastic anemia, myelodysplastic syndromes, etc.) or any disease causing hemolysis or red blood cell instability (e.g., sickle cell anemia, thalassemia, etc.); 14.(Medical history and examination) Severe diseases of other systems or organs such as the nervous system, respiratory system, immune system, liver, kidney, etc., assessed by the investigator as unsuitable for participation in the trial; 15. (Medical history and examination) Confirmed malignant tumor within 5 years prior to screening (except cured in situ carcinoma) or potential malignant tumor at screening; 16.(Medical Consultation) Individuals with severe mental illness or language barriers who are unwilling or unable to fully understand and cooperate during screening; 17.(Medical history) Known to have allergic constitution (allergic to 3 or more foods or drugs), allerg
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Glycosylated Hemoglobin;Fasting weight;fasting insulin;fasting blood-glucose;2-hour postprandial blood glucose;Fasting glucagonFasting glucagon;Fasting weight;Fasting weight;Fasting proinsulin;Fasting weight;Fasting C-peptide; | — |
Primary
| Measure | Time frame |
|---|---|
| Glycosylated Hemoglobin; | — |
Countries
China
Contacts
Public ContactYuFeng Li
Beijing Friendship Hospital Pinggu Campus,Capital Medical University
Outcome results
None listed