About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
A history of type 1 diabetes, specific diabetes, or secondary diabetes;
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;
Have a history of malignancy within 5 years;
Trial design
Treatments tested in this trial
- HRS9531
- HRS9531
- Placebo