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Tests treatment safety and results for Type 2 Diabetes
Official title Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
ClinicalTrials.gov ID: NCT07060456
What this study is testing
What is HRS9531?
HRS9531 is an investigational medicine, being studied as a potential treatment for type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.