Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated September 12, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-20.
Status change: Not Yet Recruiting → Recruiting 2025-09-10
Trial Details
NCT Number NCT06888050
Lead Sponsor Zhejiang Provincial People's Hospital
Collaborators: Shandong Suncadia Medicine Co., Ltd.
Conditions New-onset Type 2 Diabetes
Enrollment 268 participants
Start Date 2025-04-11
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-12