← Eichor
Study identifier: NCT06888050 Synced from ClinicalTrials.gov · July 29, 2026
● 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

Condition: New-onset Type 2 Diabetes  ·  Sponsor: Zhejiang Provincial People's Hospital

PhasePhase 4
Planned participants268
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Xiaohong Wu  ·  +86-13815870351  ·  drxhwu@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

Zhejiang Provincial People's HospitalHangzhou, Zhejiang, ChinaRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT06888050