Diabetes Mellitus, Type 2
Conditions
Brief summary
The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 24 weeks of treatment
Interventions
HRS9531 Injection
DRUGHRS9531 Placebo Injection
HRS9531 Placebo Injection
Sponsors
Fujian Shengdi Pharmaceutical 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. Males and females, Age ≥18 years at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening. 3. Treatment with Diet and Exercise alone at least 90 days prior to day of screening. 4. 7.5% ≤ HbA1c ≤10.0% at screening.
Exclusion criteria
1. Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.). 4. Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ； 5. Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening. 6. Participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c | from baseline to 36 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with HbA1c<7.0% and ≤6.5% | from baseline to 36 weeks treatment |
| Change in FPG | from baseline to 36 weeks treatment |
| Change in body weight | from baseline to 36 weeks treatment |
| Proportion of subjects with HbA1c<7.0% and weight loss ≥5% | from baseline to 36 weeks treatment |
Countries
China
Outcome results
None listed