Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

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

Treatment groups

300 Participants
are divided into 3 treatment groups