T2DM
Conditions
Brief summary
The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.
Interventions
DRUGRAY1225
Administered SC
DRUGSemaglutide
Administered SC
Sponsors
Guangdong Raynovent Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have been diagnosed with type 2 diabetes mellitus (T2DM) 2. Have HbA1c between ≥7.0% and ≤11.5% 3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening 4. Be of stable weight (±5%) for at least 12 weeks before screening
Exclusion criteria
1. Have type 1 diabetes mellitus 2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment; 3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization; 4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \<3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ; 5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control; 6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.); 7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg) | Baseline,36 Week | HbA1c is the glycosylated fraction of hemoglobin A. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Achieving an HbA1c Target Value of <7% | Baseline,36 Week |
| Percentage of Participants With HbA1c Target Value of <6.5% | Baseline,36 Week |
| Percentage of Participants With HbA1c Target Value of <5.7% | Baseline,36 Week |
| Mean change in fasting serum glucose | Baseline,36 Week |
| Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline | Baseline,36 Week |
Countries
China
Contacts
Primary ContactJi professor
Outcome results
None listed