Status:
COMPLETED
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
Lead Sponsor:
Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptima...
Eligibility Criteria
Inclusion
- Male or female subjects ,18-65 years of age, agreed and signed the informed consent
- Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
- Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- HbA1c 7.5-10.5% (both inclusive) at screening visit.
Exclusion
- Presence of any clinically significant results in examination at screening visit.
- Uncontrollable hypertension.
- A history of type 1 diabetes, specific diabetes, or secondary diabetes.
- Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
- History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
- Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
- Surgery is planned during the trial.
- Mentally incapacitated or speech-impaired.
- Pregnant or lactating woman.
- In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
Key Trial Info
Start Date :
August 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2024
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT05966272
Start Date
August 12 2023
End Date
September 24 2024
Last Update
May 7 2025
Active Locations (1)
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1
Shandong Provincial Hospital
Jinan, Shandong, China, 250021