Actively Recruiting
Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2026-01-02
300
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the efficacy and safety of HRS9531 compared with placebo in participants with type 2 diabetes mellitus not adequately controlled with basal insulin, with or without metformin and/or sodium-glucose cotransporter-2 (SGLT2) inhibitor. The study may include up to 23 visits.
CONDITIONS
Official Title
Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, able and willing to provide a written informed consent
- Diagnosed with type 2 diabetes for at least 90 days
- On stable once-daily dose of basal insulin alone or with metformin and/or SGLT2 inhibitor for at least 90 days
- HbA1c between 7.5% and 11.0% inclusive
- Body Mass Index (BMI) of 22 kg/m2 or higher at screening
You will not qualify if you...
- History of type 1 diabetes, specific diabetes, or secondary diabetes
- History of severe hypoglycemia within 180 days before screening
- History of acute cardiovascular or cerebrovascular diseases within 180 days before screening
- History of cancer within the past 5 years
- Known or suspected allergy or intolerance to the study drug or related products
- Participation in any clinical trial of an approved or unapproved investigational product within the last 90 days
- Any condition judged by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Perking University Peoples' Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
H
Hong Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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