Type 2 Diabetes
Conditions
Brief summary
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
DRUGHRS9531
HRS9531-low dose
DRUGPlacebo
Placebo
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | from baseline to Week 40 | Change in HbA1c after 40 weeks of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects reaching HbA1<7.0% | from baseline to Week 40 | Proportion of subjects reaching HbA1\<7.0% after 40 weeks of treatment. |
| Proportion of subjects reaching HbA1≤6.5% | from baseline to Week 40 | Proportion of subjects reaching HbA1≤6.5% after 40 weeks of treatment. |
| Change in FPG | from baseline to Week 40 | Change in FPG after 40 weeks of treatment. |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score | From baseline to Week 40 | Change from baseline in DTSQs after 40 weeks of treatment. |
Countries
China
Contacts
Primary ContactHong Chen
Outcome results
None listed