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RECRUITING
NCT06888050
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

Metformin

Metformin (500mg, twice a day) plus lifestyle intervention

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China