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

NCT07441187 | Not Yet Recruiting

• 1 other identifier: XHEC-C-2025-272-2
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

SGLT2 inhibitor

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline to Week 24.

  Week 24

Secondary Outcomes (5)

• Proportions achieving HbA1c targets

  week 24

• changes in body weight

  week 24

• adherence rate

  week 24

• systolic/diastolic blood pressure

  week 24

• fasting/postprandial glucose

  week 24

Study Arms (1)

treatment group

Drug: Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets

Interventions

Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets DRUG

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.

treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed T2DM with screening HbA1c leel between 8.0% and 11.0% (inclusive), or T2DM treated with any one oral antidiabetic drug for 60 days with a screening HbA1c level between 7.0% and 11.0%

You may qualify if:

• Male or female aged 18 to 70 years (inclusive) at the time of signing the informed consent form.
• Diagnosed with type 2 diabetes mellitus.
• Voluntarily participate in this study and sign the informed consent form. If a subject is unable to read the informed consent form (e.g., an illiterate subject), an impartial witness must be present during the entire informed consent discussion and must also sign the consent form.
• At screening, the subject must meet either of the following two criteria:
• Newly diagnosed with type 2 diabetes within 90 days prior to screening, with no prior use of any antidiabetic medication, and a screening HbA1c level between 8.0% and 11.0% (inclusive).
• Treated with any one oral antidiabetic drug \[metformin (with a stable daily dose ≥1000 mg or the maximum tolerated dose documented in the patient's medical record), an alpha-glucosidase inhibitor, a sulfonylurea, a glinide, a thiazolidinedione, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), a dipeptidyl peptidase-4 inhibitor (DPP-4i), a glucokinase activator, or an oral glucagon-like peptide-1 receptor agonist\] for at least 60 days prior to screening, with a screening HbA1c level between 7.0% and 11.0% (inclusive). The subject should have been on a stable dose of the medication for at least 30 days prior to screening.
• Body Mass Index (BMI) \>19 kg/m² and ≤40.0 kg/m².

You may not qualify if:

• Type 1 diabetes mellitus, monogenic diabetes, diabetes due to pancreatic injury, or other forms of secondary diabetes (e.g., diabetes secondary to Cushing's syndrome or acromegaly).
• Fasting C-peptide \<1.0 ng/mL (0.34 nmol/L) as measured by the local laboratory.
• Known or suspected hypersensitivity to the investigational product or related compounds.
• Participation in any other investigational drug trial within 3 months prior to the start of this study.
• Use of traditional Chinese herbal medicine for glycemic control within 2 months prior to screening (except for cumulative use ≤7 days).
• History of acute metabolic complications (e.g., ketoacidosis, lactic acidosis, hyperosmolar coma/state) within the past 6 months.
• History of decompensated heart failure (NYHA Class IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within the past 6 months.
• Severe infection, significant trauma, or major surgery within 30 days prior to screening.
• History of acute or chronic pancreatitis.
• Patients with malignancy and a life expectancy of less than one year, active tuberculosis, or acute infection.
• Current or history of recurrent urinary tract infections and/or genital infections.
• Patients with a history of hypertension whose blood pressure remains uncontrolled despite antihypertensive medication: systolic blood pressure (SBP) \>180 mmHg and/or diastolic blood pressure (DBP) \>110 mmHg.
• Systolic blood pressure \<90 mmHg at the screening visit, or patients judged by the clinician to be hypovolemic.
• Moderate to severe renal impairment (eGFR \<45 mL/min/1.73m²), end-stage renal disease, or patients on dialysis.
• Men or women of childbearing potential unwilling to use effective contraception during the trial, or women who are pregnant or breastfeeding.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

henagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02