Tests HRS9531 in adults with type 2 diabetes using basal insulin
Tests HRS9531 against a placebo in adults with type 2 diabetes on insulin.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Perking University Peoples' HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Trial code
- NCT07060456
- Record updated
- 2 January 2026
- Original description
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.Read full original descriptionShow less
A Phase III, Multicenter, Randomized, Double Blinded, Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 Versus Placebo in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal Insulin.
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.
Inclusion: Male or female, able and willing to provide a written informed consent; Diagnosed with type 2 diabetes ≥ 90 days；; On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days; HbA1c was 7.5%~11.0% (both inclusive); Body Mass Index (BMI) ≥22 kg/m2 at screening.
Exclusion: Have a history of severe hypoglycemia within t180 days prior to screening; History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；; Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days; A history of type 1 diabetes, specific diabetes, or secondary diabetes; Have a history of malignancy within 5 years; Known or suspected allergy or intolerance to the investigational medicinal products or related products; Any conditions that the Investigator judges might not be suitable to participate in the trial.