Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
Recruiting · NCT07060456 · Interventional (participants receive a specific treatment) · Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
HRS9531Placebo
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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;
- Known or suspected allergy or intolerance to the investigational medicinal products or related products;
- Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;
- Any conditions that the Investigator judges might not be suitable to participate in the trial.
Where it is running
1 location listed.
- Perking University Peoples' Hospital - Beijing, Beijing Municipality, China