A Study of 3mg Once Every Two Weeks Administration of Efsubaglutide Alfa Injection in Type 2 Diabetes Patients.

Korábbi kezelés

• Any DPP-4 inhibitors and / or GLP-1 analogues were used within 3 months before screening;
• Continuous use of insulin for more than 14 days in the previous year;
• Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non ketonic diabetic coma occurred within 6 months before screening;
• Unstable proliferative retinopathy or macular lesion, severe diabetic neuropathy, intermittent claudication or diabetic foot occurred within 6 months before screening;
• Severe hypoglycemia occurred within 6 months before screening
• Severe trauma infection or operation within one month before screening;
• Growth hormone therapy was performed within 6 months before screening;
• Patients having received corticosteroid continuous ≥ 7 days through within 2 months ;
• Use any drugs or surgery with weight control effect within 2 months;
• mean systolic pressure (SBP) ≥ 160mmhg and / or DBP ≥ 90 mmHg at screening, or new/changed antihypertensive drugs or adjusted dosage of antihypertensive drugs within 4 weeks before screening or before induction period
• with a history of severe cardiovascular disease, high risk of stroke/stroke within 6 months before screening;
• with clinically significant abnormal gastric emptying , severe chronic gastrointestinal diseases , long-term use of drugs that have a direct impact on gastrointestinal peristalsis , or having undergone gastrointestinal surgery within 6 months before screening, are not suitable to participate in this clinical study according to the evaluation of the researchers;
• drinking more than 14 standard units weekly within 6 months before screening ;
• participated in clinical trials of other drugs or devices within 3 months before screening;
• Medication compliance in the lead-in period was ≤ 50% ;

Más betegség

• Diabetes other than Type 2;
• Suspected active infection ;
• with a history of medullary thyroid cancer, multiple endocrine neoplasm (Men) 2A or 2B syndrome, or related family history;
• suffering from hematological diseases or any disease causing hemolysis or erythrocyte instability ;
• HBsAg, HCV-Ab, HIV-Ab, TPAb or COVID-19 nucleic acid tested positive;
• serious mental illness;
• a history of organ transplantation or other acquired or congenital immune system diseases;
• allergic to the active ingredients (GLP-1 and GLP-1 analogues) of the study drug;

Laborértékek

• with a history of acute or chronic pancreatitis, symptomatic gallbladder , pancreatic injury and other risk factors for pancreatitis, or with blood amylase and/or blood lipase ≥1.5 times the upper limit of normal (ULN) at the time of screening or before randomization;
• with hemoglobinopathy that may affect the determination of HbA1c levels;
• Any of the following conditions: the pacemaker was installed when screened; no pacemaker was installed, but 12 lead ECG showed degree II or III atrioventricular block, long QT syndrome or QTc interval ≥ 450ms (fridericia formula was used to calculate QTCF); Patients with New York Heart Function Classification III or IV; Or other abnormal cardiac function with clinical significance that is not suitable for clinical research judged by researchers;
• acute or chronic viral hepatitis, or whose laboratory examination indexes meet one of the following criteria at the time of screening or before randomization : alanine aminotransferase (ALT) level ≥ 2.5 fold ULN, aspartate aminotransferase (AST) ≥ 2.5 fold ULN, fasting triglyceride (TG) > 5.7 mmol/L or 500 mg/dl; the glomerular filtration rate (EGFR) < 60 ml/min/1.73 m2 was calculated by CKD-EPI (epi - (SCR)) formula;

Egyéb

• C-Peptide <0.3 nmol/L;
• Blood donation or massive blood loss or transfusion within 3 months ;
• weight change of more than 5% within 3 months;
• Calcitonin level ≥50 ng/L (pg/mL) during screening;
• Uncontrolled hyperthyroidism or hypothyroidism;
• clear contraindications for the use of metformin;
• Any other situation that researchers think may affect the patients' informed consent or compliance with the trial protocol, or the patients' participation in the trial may affect the trial results or their own safety.

• Male or female patients aged from 18 to 75;
• Type 2 diabetes diagonsed at least 8 weeks and has not received any glucose-lowering medication within 8 weeks prior to screening;
• During screening, HbA1c: 7.0% ≤ HbA1c ≤ 11.0%;
• Before randomization : 7.0% ≤ HbA1c ≤ 11.0%;
• During screening and before randomization: FPG< 13.9 mmol/L
• 24 kg/m2 ≤ BMI ≤ 40 kg/m2;
• Without birth plan and voluntarily take effective contraceptive measures;
• Fully understood the study, voluntarily entered the study and signed the informed consent.