Type 2 Diabetes Mellitus
Conditions
Interventions
Experimental group:E4F4 injection
placebo group:placebo
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years old (including 18 and 65 years old, subject to the day of signing the informed consent form), both men and women; 2.The body mass index (BMI) >19kg/m2 and =28kg/m2 (BMI=weight(kg)/height(m2), Self-reported weight change of no more than 10% in the 3 months prior to enrollment; 3.Diagnosis of type 2 diabetes >3 months before screening according to the 1999th World Health Organization (WHO) criteria for diabetes; 4.Patients with type 2 diabetes who have not been treated with hypoglycemic drugs and have poor glycemic control through diet or exercise alone, or have used a single hypoglycemic drug for no more than 4 consecutive weeks and have stopped taking it for more than 8 weeks; 5.Glycosylated hemoglobin (HbA1c) values of 7.0%-11.0% (with boundary values) at screening and fasting blood glucose values of 7.0-11.1 mmol/L (with boundary values) at screening; 6.Patients who are willing to undergo self-monitoring of blood glucose and ability to keep a diary card (paper diary of subjects); 7. Female subjects who are willing to take effective contraception within 12 months from the date of signing the informed consent form and without a childbirth plan.The blood pregnancy test at screening for female subjects is negative. 8. The subjects voluntarily participate in the trial, are able to communicate well with the investigator. The subjects also voluntarily complete the study process in accordance with the trial protocol and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes paitents or type 2 diabetes who need insulin therapy or other special types of diabetes. 2.Patiens who have had clinically significant gastric emptying abnormalities (such as gastric outlet obstruction), serious chronic gastrointestinal diseases (such as active ulcers within 6 months), diabetic gastroparesis, long-term use of drugs that have a direct impact on gastrointestinal peristalsis, or have received gastrointestinal surgery. 3.Unstable proliferative retinopathy or macular degeneration that require urgent treatment, or history of diabetic ketoacidosis, diabetic hyperosmolar non-ketosis coma, severe metabolic disorders leading to neurological or mental dysfunction within 1 year prior to randomization. 4.Serious trauma, serious infection or surgery that may affect blood glucose control within 6 month prior to screening; 5.Serious cardiac and cerebrovascular events within 6 months prior to screening, such as angina, myocardial infarction, arrhythmia, cerebrovascular embolism and cerebral hemorrhage. 6.History of acute and chronic pancreatitis, or high risk of pancreatic injury, or amylase > 1.5×ULN during screening 7.History of malignant tumors, medullary thyroid cancer (MTC) or type 2 multiple endocrine neoplasia (MEN2, including MEN2A, MEN2B), or medium to high risk thyroid nodules during thyroid ultrasound (2017 ACR TI-RADS class 4 and above). 8.blood cachexia or any disease that causes hemolysis or red blood cell instability (such as malaria, hemolytic anemia) 9.Patients with hemoglobin disease that may affect the determination of HbA1c level (such as sickle-type erythrocyte disease); 10.Diagnosed of malignant tumor within 5 years (except for carcinoma in situ of cervix and carcinoma in situ of prostate) 11.History of organ transplantation or other acquired or congenital immune system diseases; 12.Patients with mental illnes that may intervene the research, such as schizophrenia. 13.Any unstable or blood glucose-related endocrine system diseases that require treatment, (such as hyperthyroidism, acromegaly syndrome, Cushing syndrome, etc.), unsuitable for the research in the investigator’s judgement. 14.Patients with history of hypertension and systolic blood pressure (SBP) > 150 mmHg and / or diastolic blood pressure (DBP) >90 mmHg after a stable dose (at least 4 weeks) of antihypertensive drug . 15.Patients who are currently receiving or plan to reveive weight-loss drug or have received weight-loss drug within 3 months prior to screening 16.Have received GLP-1R analogue within 3 months prior to screening. 17.Have received drugs that affect the regulation of blood glucose within 3 months prior to screening, such as glucocorticoids, growth hormones, thyroxine, sex hormones, cyclosporine, phenytoin, etc. 18.Fasting C-peptide 2× upper limit of normal (ULN); bilirubin >2×ULN (except for known Gilbert syndrome that meets the requirements below, i.e. partial bilirubin indicates binding bilirubin <35% total bilirubin); Triglycerides = 5.7 mmol/L; Estimated creatinine clearance < 60 mL/min (estimated by the Cockroft-Gholt formula), etc.; Clinically significant anemia with hemoglobin <
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Pharmacokinetics (PK);Pharmacodynamics (PD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity; | — |
Countries
China
Contacts
Public ContactLixin Guo
Beijing Hospital
Outcome results
None listed