Actively Recruiting
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study
Led by Zhejiang Provincial People's Hospital · Updated on 2025-09-12
268
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Provincial People's Hospital
Lead Sponsor
S
Shandong Suncadia Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multicenter, randomized controlled trial aims to evaluate the efficacy and safety of Henagliflozin-Metformin Sustained-Release Tablets (I) versus Metformin Tablets in newly diagnosed type 2 diabetes mellitus (T2DM). A total of 268 participants will be randomized (1:1) into two groups: the experimental group receiving Henagliflozin-Metformin Sustained-Release Tablets (I) (5mg/500mg, once daily) with lifestyle intervention, and the control group receiving Metformin Tablets (500mg, twice daily) with lifestyle intervention. The primary outcome is the change in glycated hemoglobin (HbA1c) from baseline at 24 weeks. Secondary outcomes include changes in fasting/postprandial blood glucose, body weight, metabolic parameters, diabetes remission rate, and safety assessments. This trial will provide evidence for early combination therapy in newly diagnosed T2DM patients.
CONDITIONS
Official Title
Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Diagnosed with type 2 diabetes according to WHO criteria with HbA1c between 7% and 9%, fasting venous blood glucose ≤ 11.1 mmol/L, and BMI ≥ 18.5 kg/m2
- Known diabetes duration of 24 months or less
- Voluntary participation and signed informed consent
- No previous use of hypoglycemic drugs
You will not qualify if you...
- Type 1 diabetes diagnosis
- Participation in other diabetes drug clinical trials before this study
- History of diabetic ketoacidosis, lactic acidosis, or hyperosmolar non-ketotic coma requiring hospitalization in past six months
- History of severe heart conditions or stroke within past six months
- Use of systemic glucocorticoid drugs
- Life expectancy under one year due to cancer, active tuberculosis, or acute infections
- Significant urinary or genital infections or recurrent infections
- Uncontrolled hypertension despite treatment with systolic >160 mmHg or diastolic >100 mmHg
- Liver enzymes ALT or AST ≥ 3 times upper limit of normal
- Estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73 m2
- Allergy to the study drug or components
- Pregnant or breastfeeding women or intending to conceive within three months of last dose
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
Xiaohong Wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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