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Efficacy and Safety of Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets in Chinese Patients With Type 2 Diabetes Mellitus

NCT07441187 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-02-27

No results posted yet for this study

Summary

Given the significant and growing burden of Type 2 Diabetes (T2DM) in China, there is a continuous need for effective, convenient, and well-tolerated treatment strategies. This Phase IV, multicenter, prospective, observational study aims to evaluate the real-world effectiveness and safety of a novel, once-daily, fixed-dose combination (FDC) tablet containing Henagliflozin (SGLT2 inhibitor), Retagliptin (DPP-4 inhibitor), and Metformin Extended-Release in Chinese patients with T2DM. The study plans to enroll approximately 300 patients across 30 sites, stratified into two cohorts: newly diagnosed, drug-naïve patients and those with inadequate glycemic control on a single prior oral antidiabetic drug. The primary objective is to assess the change in Glycated Hemoglobin (HbA1c) from baseline after 24 weeks of treatment. Key secondary objectives include evaluating the proportion of patients achieving HbA1c targets (\<7.0% and ≤6.5%), assessing changes in other metabolic parameters such as body weight, blood pressure, fasting and postprandial glucose, and lipid profiles, and monitoring treatment adherence. The safety evaluation will comprehensively document all adverse events, with special attention to events of interest including hypoglycemia, urinary/genital infections, volume-related events, and diabetic ketoacidosis. The study design includes a screening period, a 2-week run-in with lifestyle intervention, a 24-week core treatment period where eligible patients receive the FDC therapy, and a final safety follow-up. Efficacy and safety assessments are scheduled at baseline, Week 4, Week 12, and Week 24. Statistical analysis will be primarily descriptive, focusing on changes from baseline for continuous endpoints and frequency distributions for categorical endpoints, with analyses conducted separately for the two patient cohorts. The study will be conducted in full compliance with Good Clinical Practice (GCP), the Declaration of Helsinki, and relevant Chinese regulations, requiring prior ethics committee approval and written informed consent from all participants. This real-world evidence study seeks to confirm the clinical benefits and safety profile of this triple-combination therapy observed in earlier controlled trials, providing practical insights into its use in routine management of T2DM within the Chinese healthcare context.

Conditions

  • T2DM (Type 2 Diabetes Mellitus)

Interventions

DRUG

Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets

After the run-in period, eligible patients who meet the criteria for receiving the investigational drug will discontinue their prior antidiabetic therapy. Based on the investigator's clinical judgment of the patient's condition, the investigational drug Henagliflozin/Retagliptin/Metformin Extended-Release Tablet (containing Henagliflozin 10 mg, Retagliptin Phosphate 100 mg, and Metformin Hydrochloride 1000 mg per tablet) will be prescribed. The dosage is one tablet once daily in the morning, taken with or without food. It is recommended to take the medication at approximately the same time each day. The tablet should be swallowed whole and must not be chewed.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-20
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07441187 on ClinicalTrials.gov