Type 2 Diabetes
Conditions
Brief summary
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.
Interventions
DRUGHRS-7535 tablet
HRS-7535 tablet
dapagliflozin tablet
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
HRS-7535 tablet compared with dapagliflozin tablet
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c at 32 weeks of treatment | at 32 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants Who Achieved HbA1c <7.0% at Week 32 | at 32 weeks |
| Change from Baseline in Fasting Serum Glucose, from Baseline to Week 32 | at 32 weeks |
| Percentage of Participants Who Achieved HbA1c ≤6.5% at Week 32 | at 32 weeks |
| Change from Baseline in Body Weight, from Baseline to Week 32 | at 32 weeks |
| Change from Baseline in Waist Circumference, from Baseline to Week 32 | at 32 weeks |
| Percentage Change from Baseline in Body Weight, from Baseline to Week 32 | at 32 weeks |
Countries
China
Contacts
Primary ContactJian Lei
Outcome results
None listed