HRS9531 added to basal insulin for people with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Perking University Peoples' Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Hong Chen
• Email: hong.chen@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.