RecruitingPhase 4NCT06888050

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

Enrollment

268 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

New-onset Type 2 Diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares a combination pill (henagliflozin + metformin extended-release) against metformin alone as a first treatment for people newly diagnosed with type 2 diabetes. Henagliflozin is a newer drug that helps the kidneys remove excess sugar from the body. **You may be eligible if...** - You are between 18 and 75 years old - You were recently diagnosed with type 2 diabetes (within the last 2 years) - Your HbA1c (a blood sugar control measure) is between 7% and 9% - Your fasting blood sugar is not extremely high - Your BMI is at least 18.5 kg/m² **You may NOT be eligible if...** - You have already taken diabetes medications - You have significant kidney, liver, or heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGhenagliflozin 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

DRUGMetformin

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

Locations(1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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NCT06888050