Overweight or obese people with type 2 diabetes
Conditions
Interventions
Semaglutide 0.5mg group:0.5mg semaglutide
Semaglutide 1.0mg group:1.0mg semaglutide
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Obtain informed consent; 2. The investigator determines that the treatment of diabetes requires the use of semaglutide, and the subject consents to the use of the drug; 3. Male or female, 18 years old =24 kg/m^2; 5. Hemoglobin A1c (HbA1c) 7.0% =180 days before screening date; 7. Receive any of the following: treatment with diet and exercise alone, or at least 60 days prior to the screening date, with stabilization (same drug, dose, and frequency of administration), and up to 3 oral hypoglycemic agents alone or in combination according to the instructions (metformin, alpha-glucosidase inhibitors, sulfonylureas, glenides).
Exclusion criteria
Exclusion criteria: 1. Receiving GLP-1RA or weight loss medication within 180 days prior to screening; 2. Self-reported weight change >5 kg within 90 days; 3. Had received any medication indicated for obesity within 90 days prior to screening, and had been or planned to be treated for obesity with surgery or weight-loss devices during the trial; 4. Uncontrolled and potentially unstable diabetic retinopathy or macular degeneration, verified by fundus examination performed within 90 days prior to or during screening; 5. Poorly controlled thyroid disease, defined as thyroid stimulating hormone (TSH) >4.34 mIU/L or <0.38 mIU/L; 6. History of acute or chronic pancreatitis; 7. Blood calcitonin =50 ng/L or personal/first-degree relatives have a history of MEN2 or medullary thyroid cancer; 8. Known or suspected allergy to the investigational drug or related drug; 9. Complicated with definite acute diabetic complications; 10. Complicated with severe cardiac, hepatic and renal insufficiency (cardiac function grade IV, ALT or AST =3 times normal, eGFR =45 mL/min/1.73 m^2); 11. Stress factors such as fever, acute infection, surgery, or trauma exist within 180 days; 12. Combined tumor; 13. A woman who is pregnant, breastfeeding or planning a pregnancy, or a woman who is fertile and not using effective contraception; 14. Have a history of mental illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Four Bone Metabolism Markers (Osteocalcin, ß-Crosslaps, Total Type I Collagen C-Telopeptide, and 25-Hydroxyvitamin D);Muscle mass;BMD(bone mineral density); | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Sugar;Liver function;Electrolyte;Blood lipid;Urine MA/Cre;Fasting plasma glucose;Visceral fat area;Fasting C-peptide;Glycosylated hemoglobin;Routine urine test;Blood routine examination;Renal function;Calcitonin;Fasting insulin; | — |
Countries
China
Contacts
Public ContactMen Lili
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed