RECRUITINGPhase 3INTERVENTIONAL
Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
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.
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Male or female, able and willing to provide a written willing to sign a consent form
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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
HRS9531
HRS9531-low dose
DRUG
HRS9531
HRS9531-high dose
DRUG
Placebo
Placebo
Locations (1)
Perking University Peoples' Hospital
Beijing, Beijing Municipality, China