Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS9531, HRS9531, Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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.
Overview
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.
Interventions
- Drug HRS9531
HRS9531-low dose - Drug HRS9531
HRS9531-high dose - Drug Placebo
Placebo
Primary outcome measures
- Change in HbA1c [Time frame: from baseline to Week 40]
Secondary outcome measures (4)
- Proportion of subjects reaching HbA1<7.0% [Time frame: from baseline to Week 40]
- Proportion of subjects reaching HbA1≤6.5% [Time frame: from baseline to Week 40]
- Change in FPG [Time frame: from baseline to Week 40]
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score [Time frame: From baseline to Week 40]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Perking University Peoples' Hospital — Beijing
Identifiers
NCT: NCT07060456 · HRS9531-305