Not yet recruiting NCT07139548
A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RAY1225, Semaglutide.
- Who it may be relevant to
- Registry conditions: T2DM. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes
Overview
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
- Drug RAY1225
Administered SC - Drug Semaglutide
Administered SC
Primary outcome measures
- Change From Baseline in Hemoglobin A1c (HbA1c) (6 mg and 9 mg) [Time frame: Baseline,36 Week]
Secondary outcome measures (5)
- Percentage of Participants Achieving an HbA1c Target Value of <7% [Time frame: Baseline,36 Week]
- Percentage of Participants With HbA1c Target Value of <6.5% [Time frame: Baseline,36 Week]
- Percentage of Participants With HbA1c Target Value of <5.7% [Time frame: Baseline,36 Week]
- Mean change in fasting serum glucose [Time frame: Baseline,36 Week]
- Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline [Time frame: Baseline,36 Week]
Eligibility criteria
Inclusion criteria
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- Have HbA1c between ≥7.0% and ≤11.5%
- Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
- Be of stable weight (±5%) for at least 12 weeks before screening
Exclusion criteria
- Have type 1 diabetes mellitus
- 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;
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
- 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 ;
- History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
- 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.);
- 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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07139548 · RAY1225-24-13