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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
Sponsor: Zhejiang Provincial People's Hospital
Summary
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
268
Start Date
2025-04-11
Completion Date
2026-12-30
Last Updated
2025-09-12
Healthy Volunteers
No
Conditions
Interventions
henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ)
henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) (5mg/500mg, once a day, two tablets each time) plus lifestyle intervention
Metformin
Metformin (500mg, twice a day) plus lifestyle intervention
Locations (1)
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China