diabetes
Conditions
Interventions
1:Polyethylene glycol loxenatide
2:Insulin glargine
Sponsors
beijing hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: To be enrolled, the following criteria must be met simultaneously: voluntarily participate in this study and sign Informed consent form; Age greater than or equal to 60 years old, regardless of gender; BMI 19-40.0 kg/m2 during screening (including critical values); Diagnosis of type 2 diabetes (in line with the Chinese Guidelines for the Diagnosis of Elderly diabetes 2020 Diagnostic criteria for the annual edition); Prior to screening, diet and exercise control have been carried out, and 2 or more have been taken orally The hypoglycemic drugs on (excluding DPP4 inhibitors) have remained stable in dosage for the past 8 weeks; Glycated hemoglobin 7-11%(including critical values)
Exclusion criteria
Exclusion criteria: If one of the following criteria is met, it can be ruled out: Those who have experienced severe hypoglycemic events with recurrent episodes (= 3 times) within 6 months; Acute complications of diabetes (Diabetic ketoacidosis, non ketotic hyperosmolality) occurred within 6 months Coma, diabetes, Lactic acidosis, etc.); Individuals with proliferative retinopathy and/or macular degeneration that urgently require treatment; History of acute or Chronic pancreatitis, acute or Chronic pancreatitis at random, or screening Blood Amylase = 3 times the upper limit of normal value, or pancreatectomy has been performed; Individuals with a history of multiple endocrine tumor syndrome type 2 (MEN 2) or related family history; Having a history of medullary thyroid carcinoma (MTC) or a family history, or Genetic disorder is easy to induce thyroid Patients with myeloid carcinoma; Individuals with thyroid dysfunction who have failed to control stability (control stability refers to receiving stability for at least 3 months) Fixed dose of Thyroid hormones replacement or antithyroid drugs and thyroid function in normal range Surrounding); Used Glucagon-like peptide-1 receptor agonist and dipeptidyl peptidase within 3 months -4 (DPP-4) inhibitor or any other incretin Insulin analog; Have used insulin continuously for more than 7 days within 3 months, or have used insulin within the first month of randomization Person; Use systemic Corticosteroid for>7 days within 3 months (excluding topical, eye Nasal spray or inhalation preparation) or need to continue to accompany for a long time (>7 days) during the test Patients treated with Corticosteroid; Currently taking or planning to take Anti-obesity medication during the study period, or within 3 months before randomization Passed Anti-obesity medication, or the weight change exceeded 10% in the first three months of randomization; Those with triglycerides = 5.7 mmol/L during screening; Alanine aminotransferase (ALT) and/or Aspartate transaminase (AST) are large during screening At 3 times the upper limit of normal value (ULN); When screening, the glomerular filtration rate (eGFR) with impaired renal function was less than 45 mL/min/1.73m2; EGFR Calculated by serum creatinine level, eGFR=175 × Serum creatinine (Scr) -1.234 × Age -0.179[ × 0.79 female], 1mg/dL=88.4 µ Mol/L); When screening, hemoglobin levels for males160 mmHg and/or diastolic blood pressure(DBP)>100 mmHg); Suffer from the following heart diseases or Cerebrovascular disease: unstable angina pectoris within 6 months before screening Author; Individuals who have had cardiac insufficiency (NYHA Level III or IV) within 6 months; History of myocardial infarction, Coronary stent implantation or Coronary artery bypass surgery operation within 6 months Person;Newly reported cerebrovascular accidents within 6 months (including ischemic stroke, hemorrhagic stroke, andTransient ischemic attack); Individuals with uncontrolled severe arrhythmia within 6 months; Diagnosed with malignant tumors within 5 years; Known allergies to experimental drugs or excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1C; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visceral fat content;blood lipid;EAT-26/SF-36 scale scoring;Dynamic blood glucose monitoring indicators; | — |
Countries
CHINA
Contacts
Public ContactDongni Yu
beijing hospital
Outcome results
None listed