T2DM
Conditions
Brief summary
The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
Interventions
DRUGRAY1225
Administered SC
DRUGplacebo
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. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents. 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) | Baseline,36 Week | HbA1c is the glycosylated fraction of hemoglobin A. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactJI professor
Outcome results
None listed