Comparing HRS-7535 and Dapagliflozin for Type 2 Diabetes Management
A Phase 3, Randomized, Double-blinded Study to Evaluate the Efficacy and Safety of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin (OUTSTAND-2)
This study is testing a new diabetes medication called HRS-7535 to see if it works better than dapagliflozin for adults with type 2 diabetes who haven't been able to control their blood sugar with metformin.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong Suncadia Medicine Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06589765 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy and safety of HRS-7535 compared to dapagliflozin in adults with type 2 diabetes who have not achieved adequate glycemic control with metformin. Participants aged 18 to 75 with a diagnosis of type 2 diabetes for at least three months and specific HbA1c levels will be enrolled. The study involves administering either HRS-7535 or dapagliflozin tablets to assess their effectiveness in improving blood sugar levels. The trial aims to provide insights into alternative treatment options for patients struggling with diabetes management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with type 2 diabetes diagnosed for at least three months and currently on metformin treatment.
Not a fit: Patients with type 1 diabetes or those with acute diabetes complications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new treatment option for patients with type 2 diabetes who are not adequately controlled on metformin alone.
How similar studies have performed: Other studies have shown success with similar approaches in managing type 2 diabetes, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, 18-75 age years, both inclusive; 2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; 3. HbA1c 7.5-11.0% (both inclusive) at screening; 4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening. Exclusion Criteria: 1. Known or suspected allergy to the investigational drug or its components or excipients. 2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening. 4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 5. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jian Lei
- Email: jian.lei.jl9@hengrui.com
- Phone: 00-86-518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.