A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Di… (NCT06925334) | Clinical Trial Compass
By InvitationPhase 4
A Study Comparing Degu Insulin Liraglutide Injection With Premixed Insulin on the Prognosis of Diabetes Mellitus
China170 participantsStarted 2024-05-20
Plain-language summary
A randomized open, positive parallel controlled clinical study design was adopted. Participants were randomly assigned 1:1 according to inclusion criteria and exclusion criteria into two treatment regiments: Delu insulin liraglupeptide injection group and premixed insulin (or premixed insulin analogue). After fasting blood glucose was controlled at 7.5mmol /l in the morning, blood glucose was monitored by CGM (14d), and the Time in Range (3.9-10 mmol/l) was compared. Glycated albumin was measured and stool samples were taken before treatment and at 4 weeks.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the informed consent form;
✓. Male and female between the ages of 18 and 75 (inclusive);
✓. Diagnosed with type 2 diabetes mellitus according to WHO standards (1999) for more than 6 months;
✓. Those who use premixed human insulin or insulin analogues with or without oral hypoglycemic drugs (which cannot contain secretagogues and DPP4 inhibitors) \>=3 months, and have poor blood sugar control;
✓. Glycosylated hemoglobin \> 7.0% and \<=8.0% at screening;
✓. Body mass index (BMI) \> 18 kg/m\^2 and \<=35 kg/m\^2;
✓. Those who are willing and able to use the blood glucose meter for self-blood glucose monitoring according to the requirements of the program.
Exclusion criteria
✕. People who are known to be allergic to Degu insulin or ingredients in its preparations;
✕. Human glucagon-like peptide-1 (GLP-1) receptor agonist has been used within 3 months before screening;
What they're measuring
1
Time to blood glucose compliance
Timeframe: From the time of enrollment and signing of informed consent, the program started when blood glucose was controlled at 7.5 mmol/l for 14 days
✕. Patients with hypoglycemic coma within 3 months before screening;
✕. Patients with severe ketosis or ketoacidosis within 1 month before screening;
✕. Severe complications of diabetes at the time of screening: such as severe proliferative diabetic retinopathy, a history of kidney transplantation, active peripheral vascular disease (such as diseases that have led to amputation, chronic foot ulcers, intermittent claudication, or require interventional procedures such as bypass or angioplasty);
✕. Severe hypertension that cannot be controlled by treatment (defined as systolic blood pressure of not less than 180mmHg and/or diastolic blood pressure of not less than 100mmHg);
✕. Patients with acute myocardial infarction, uncontrolled angina pectoris, uncontrolled arrhythmia, or severe heart failure (NYHA grading ≥III) in the 12 months prior to screening; New cerebrovascular accidents (including ischemic stroke, hemorrhagic stroke and transient ischemic attack) within 6 months prior to screening;
✕. Liver and kidney function impairment: ALT, AST greater than 2.5 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal;