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

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.

Study Overview

• Status: Recruiting
• Conditions: New-onset Type 2 Diabetes
• Intervention / Treatment: Drug: henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ); Drug: Metformin

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xiaohong Wu; Phone Number: +86-13815870351; Email: drxhwu@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Fei Cao; Phone Number: +86-17805050859; Email: caofei1616@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 75 years old.
• Diagnosed with type 2 diabetes according to WHO diagnostic criteria, with HbA1c between 7% and 9% at this examination, fasting venous blood glucose ≤ 11.1 mmol/L, and BMI ≥ 18.5 kg/m2; known disease duration ≤ 24 months.
• Voluntary participation in this study and signing of the informed consent form. If the subject is unable to read the informed consent form (e.g., illiterate subjects), a witness must be present to observe the informed consent process and sign the informed consent form on their behalf.
• No previous use of hypoglycemic drugs.

Exclusion Criteria:

• Type 1 diabetes.
• Participants who have participated in other clinical trials of diabetes treatment drugs before the start of this study.
• Those who have experienced diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non-ketotic coma within the past six months and required hospitalization.
• Those who have experienced decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, undergone cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within the past six months.
• Those taking glucocorticoid drugs (excluding topical or inhaled medications).
• Those with a life expectancy of less than one year due to malignant tumors, active tuberculosis, or acute infections.
• Those with clinically significant urinary tract or genital infections, or a history of recurrent urinary tract or genital infections.
• Those with a history of hypertension whose blood pressure has not been effectively controlled despite antihypertensive drug treatment: systolic blood pressure (SBP) > 160 mmHg and/or diastolic blood pressure (DBP) > 100 mmHg.
• Those with liver and kidney function indicators meeting the following criteria: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 3.0×ULN; estimated glomerular filtration rate (eGFR) < 45 ml/min/1.73 m² (calculated according to the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
• Those allergic to the investigational drug or its components.
• Pregnant or lactating women and those with the intention to conceive within three months of the last dose.
• Other patients deemed unsuitable for participation in this clinical trial by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ); Start with henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) (5mg/500mg, once a day, two tablets at a time) + raw live-style intervention	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
Active Comparator: metformin; Initiation of metformin (500 mg twice a day) + lifestyle intervention	Drug: Metformin; Metformin (500mg, twice a day) plus lifestyle intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Glycosylated Hemoglobin, Type A1C（HbA1C）	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Fasting blood glucose (FBG)	4,12, 24 weeks
2-hour postprandial blood glucose (PBG)	4,12, 24 weeks
Diabetes reversal rate	36 weeks
fasting insulin/C-peptide and postprandial 2-hour insulin/C-peptide	24 weeks
HbA1c	4, 12weeks
Blood lipids (high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG])	12, 24 weeks
blood urine acid	12, 24 weeks
Urinary Albumin-to-Creatinine Ratio (UACR)	12, 24 weeks
body weight	4,12, 24 weeks

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Collaborators: Shandong Suncadia Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Organic Chemicals; Biguanides; Guanidines; Amidines; Metformin
• Other Study ID Numbers: KT20240056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No