Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to learn more about the Tolerability of RAY1225 in participants with type 2 diabetes mellitus. The study will also explore the efficacy of RAY1225. The study will last about six months for each participant.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAY1225 (cohort 1) | Experimental | Participants received dose1 or dose2 RAY1225 administered subcutaneously (SC) once two week for 24 weeks. |
|
| Placebo (cohort 1) | Placebo Comparator | Participants received Placebo administered SC once two weeks for 24 weeks. |
|
| RAY1225 (cohort 2) | Experimental | Escalating doses of RAY1225 administered subcutaneously (SC) once two week |
|
| Placebo (cohort 2) | Placebo Comparator | Participants received Placebo administered SC once two week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAY1225 | Drug | Administered SC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | HbA1c is the glycosylated fraction of hemoglobin A. | Baseline,Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HbA1c Target Value of <6.5% | Baseline,Week26 | |
| Percentage of Participants With HbA1c Target Value of <7% | Baseline,Week26 | |
| Percentage of Participants With HbA1c Target Value of <5.7% |
Not provided
Inclusion Criteria:
Type 2 diabetes had been diagnosed for at least 12 weeks prior to screening and one of the following conditions:
BMI ≥ 20 kg/m²;
Fasting blood-glucose(FPG)<15 mmol/L;
Weight change < 5% in the 12 weeks before screening;
Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijingcun | Hebei | China |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Administered SC |
|
| Baseline,Week26 |
| Change From Baseline in Fasting Serum Glucose | Baseline,Week26 |
| D004700 | Endocrine System Diseases |