Type 2 diabetes
Conditions
Interventions
Traditional CSII Group:Insulin pump
IDegLira combined with OADs group:Insulin Degludec and Liraglutide Injection combined with oral anti-hyperglycemia medicine
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Early diagnosis T2DM; 2.HbA1c>=7%; 3.Able and willing to sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Diagnosis of Type 1 Diabetes Mellitus, or presence of acute diabetic complications during the screening period (including Diabetic Ketoacidosis - DKA, Hyperosmolar Hyperglycemic State - HHS, lactic acidosis); severe microvascular complications: proliferative retinopathy; Urinary Albumin Excretion Rate (AER) >300 mg/g or positive for proteinuria with quantitative excretion >0.5 g/day; uncontrolled painful diabetic neuropathy. 2.Clinically significant hepatobiliary diseases, such as chronic active hepatitis with or without severe hepatic insufficiency. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >= 3 times the Upper Limit of Normal (ULN), or total bilirubin >=34.2 µmol/L (>= 2 mg/dL); 3.Severe renal impairment or end-stage renal disease (estimated Glomerular Filtration Rate - eGFR <= 30 mL/min/1.73 m^2). 4.Significant macrovascular complications: Within 3 months prior to signing the informed consent form, the investigator assesses that the subject has a history of the following cardiovascular diseases: myocardial infarction, cardiac surgery or angioplasty (coronary artery bypass grafting or percutaneous coronary angioplasty), unstable angina, unstable heart failure, congestive heart failure classified as New York Heart Association (NYHA) Class IV, transient ischemic attack or severe cerebrovascular disease, unstable or previously undiagnosed arrhythmia; transient ischemic attack or severe cerebrovascular disease, peripheral arterial disease requiring vascular intervention or amputation. 5.Systemic infection or severe concomitant diseases; patients with malignancy or chronic diarrhea; patients with a history of pancreatitis or Medullary Thyroid Carcinoma; 6.Use of medications that may significantly affect blood glucose levels for a cumulative duration of more than 1 week within 12 weeks prior to screening, such as alcohol abuse, oral/intravenous corticosteroids, Growth Hormone (GH), estrogen/progestin, high-dose diuretics, antipsychotic medications, etc; 7.Pregnant women with a positive pregnancy test, women intending to become pregnant during the study period, lactating women, or women of childbearing potential not using highly effective and medically approved contraception methods; 8.Having taken investigational drugs from other clinical trials within 30 days prior to the administration of the study drug in this trial, or current participation in another clinical trial (receiving drug intervention or within the follow-up observation period); 9.In the judgment of the investigator, the subject is unable to comply with the requirements of this study protocol, or has any severe medical or psychiatric condition that may affect the evaluation of efficacy and safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the glycemic remission rate at 3 months after treatment discontinuation between newly diagnosed T2DM patients receiving short-term intensive therapy with IDegLira plus OADs versus CSII.; | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the total insulin dosage, time to glycemic target, and glycemic target achievement rate between the two group; | — |
Countries
China
Contacts
Public ContactYanmei Zeng
Southern Medical University Southern Hospital
Outcome results
None listed