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

Fujian Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: HRS9531; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07060456

HRS9531-305

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, able and willing to provide a written informed consent
2. Diagnosed with type 2 diabetes ≥ 90 days；
3. On stable once-daily dose of basal insulin alone or in combination with metformin and/or SGLT2 inhibitor ≥ 90 days;
4. HbA1c was 7.5%~11.0% (both inclusive);
5. Body Mass Index (BMI) ≥22 kg/m2 at screening.

Exclusion criteria

1. A history of type 1 diabetes, specific diabetes, or secondary diabetes;
2. Have a history of severe hypoglycemia within t180 days prior to screening;
3. History of acute cardiovascular and cerebrovascular diseases within 180 days prior to screening；
4. Have a history of malignancy within 5 years;
5. Known or suspected allergy or intolerance to the investigational medicinal products or related products;
6. Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 90 days;
7. Any conditions that the Investigator judges might not be suitable to participate in the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 3 patient groups, including a placebo group

Treatment group A: HRS9531-low dose

Experimental group

Treatment:

Drug: HRS9531

Drug: HRS9531

Treatment group B: HRS9531-high dose

Experimental group

Treatment:

Drug: HRS9531

Drug: HRS9531

Treatment group C

Placebo Comparator group

Treatment:

Drug: Placebo