HRS9531 added to basal insulin for people with type 2 diabetes

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.

This test will see if adding HRS9531 to basal insulin helps lower blood sugar more than a placebo in people with type 2 diabetes whose glucose is not well controlled on basal insulin.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07060456 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study compares HRS9531 with placebo in adults with type 2 diabetes who remain above target blood sugar levels despite being on a stable once-daily basal insulin regimen, with or without metformin and/or an SGLT2 inhibitor. Eligible participants have an HbA1c between 7.5% and 11.0% and a BMI of at least 22 kg/m2, and the study may include up to 23 clinic visits for treatment and monitoring. Safety and effects on glycemic control will be tracked throughout the treatment period, and investigators will monitor for adverse events including hypoglycemia. The sponsor is Fujian Shengdi Pharmaceutical Co., Ltd., and recruitment is taking place at a study site in Beijing.

Who should consider this trial

Good fit: Adults with type 2 diabetes for at least 90 days who are on a stable once-daily basal insulin regimen (with or without metformin and/or an SGLT2 inhibitor), have HbA1c between 7.5% and 11.0%, a BMI ≥22 kg/m2, and can give informed consent are the intended participants.

Not a fit: People with type 1 or secondary diabetes, recent severe hypoglycemia or recent acute cardiovascular/cerebrovascular events, recent malignancy, known allergy to the study medication, recent participation in another investigational trial, or other conditions judged unsuitable by the investigator may not receive benefit from participation.

Why it matters

Potential benefit: If successful, HRS9531 could provide better blood-sugar control for people with type 2 diabetes who are not adequately controlled on basal insulin alone.

How similar studies have performed: Adding non-insulin glucose-lowering agents to basal insulin has shown benefit in prior trials, but HRS9531 itself is a novel investigational product and its phase 3 efficacy and safety are unproven.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality

• Perking University Peoples' Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hong Chen

Conditions Type 2 Diabetes