NCT06589765CompletedPhase 3
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin
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)
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 compared with dapagliflozin in subjects with type 2 diabetes mellitus with inadequate glycemic control using metformin.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 810 (actual)
- First submitted
- 6 Sept 2024
- Start date
- 27 Sept 2024
- Primary completion date
- 29 May 2026
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT06589765
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 810
- From 27 Sept 2024 to the primary completion date, 29 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected allergy to the investigational drug or its components or excipients.
- Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
Other illness
- Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
Other
- Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
Who the study is looking for
- Male or female, 18-75 age years, both inclusive;
- Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
- HbA1c 7.5-11.0% (both inclusive) at screening;
- Treated with conventional lifestyle intervention and stable treatment with metformin (≥1500 mg/day) at least 8 weeks prior to screening.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.