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T2DM (Type 2 Diabetes Mellitus)NCT07441187

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

An observational study of T2DM (Type 2 Diabetes Mellitus), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
T2DM (Type 2 Diabetes Mellitus)
What is being tested?
Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets
Type of treatment
Pill or oral medicine
How many people
300 participants
Where
No sites listed yet
Study dates
20 Feb 2026to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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%

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Alanine aminotransferase (ALT) >3.0 x ULN and/or aspartate aminotransferase (AST) >3.0 x ULN and/or total bilirubin >2.0 x ULN (upper limit of normal).
  • Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in this clinical trial.

About this study

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.

Read the detailed description
  1. Rationale China faces a high and growing burden of Type 2 Diabetes (T2DM). This Phase IV study evaluates a novel, once-daily, oral triple-combination therapy in a real-world setting. The fixed-dose combination (FDC) contains Henagliflozin (SGLT2 inhibitor), Retagliptin (DPP-4 inhibitor), and Metformin XR. These agents have complementary mechanisms: SGLT2 inhibition increases urinary glucose excretion, DPP-4 inhibition enhances incretin effects, and metformin reduces hepatic glucose output and improves insulin sensitivity. Prior Phase III data showed superior glycemic efficacy of this triple combination versus dual therapy. This study aims to confirm its effectiveness and safety in routine clinical practice.
  2. Objectives \& Endpoints Primary Objective: To evaluate the change in HbA1c from baseline after 24 weeks of FDC treatment. Secondary Objectives: To assess the proportion of patients achieving HbA1c targets (<7.0%, ≤6.5%), glycemic control without hypoglycemia, adherence, and changes in other metabolic parameters (weight, blood pressure, lipids, glucose). Safety Objective: To evaluate the FDC's safety profile. Primary Endpoint: Change in HbA1c from baseline to Week 24. Key Secondary Endpoints: Proportions achieving HbA1c targets; changes in body weight, systolic/diastolic blood pressure, fasting/postprandial glucose, lipid profiles; adherence rate; hypoglycemic events. Safety Endpoints: Incidence of Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (e.g., hypoglycemia, urinary/genital infections, volume depletion, diabetic ketoacidosis, acute kidney injury).
  3. Study Design This is a multicenter, prospective, observational, dual-cohort study targeting 300 patients from ~30 sites. Cohort 1 (n≈100): Newly diagnosed, drug-naïve T2DM (HbA1c 8.0-11.0%). Cohort 2 (n≈200): Patients with inadequate control (HbA1c 7.0-11.0%) on one prior oral antidiabetic drug (OAD). Study Flow: Screening/Run-in (Up to 5 weeks): Eligibility confirmed. A 2-week run-in involves lifestyle intervention (all) + continuation of prior OAD (Cohort 2 only). Treatment (24 weeks): Eligible patients start FDC tablet (one tablet QD). Assessments at Weeks 4, 12, and 24. Safety Follow-up: Telephone follow-up 7 days after last dose.
  4. Key Eligibility Inclusion: Age 18-70; T2DM diagnosis; meets Cohort 1 or 2 criteria; BMI >19 \& ≤40 kg/m². Exclusion: Type 1 diabetes; significant cardiovascular/renal/hepatic disease; history of pancreatitis, recurrent UTIs/ genital infections; pregnancy.
  5. Assessments Efficacy: HbA1c, fasting plasma glucose, 2h postprandial glucose (meal tolerance test), insulin/C-peptide, body weight, waist circumference, blood pressure, lipid profile, uric acid. Safety: Physical exams, vital signs, lab tests (hematology, biochemistry, renal/hepatic function, urinalysis), and continuous AE monitoring.
  6. Statistical Plan Analysis Populations: Full Analysis Set (FAS): Primary efficacy population. Safety Set (SS): All patients receiving ≥1 dose. Analysis: Descriptive statistics. Changes from baseline presented as mean ± SD with 95% CI. Analyses performed separately for both cohorts. One interim analysis is planned.
  7. Ethics \& Compliance The study will be conducted per ICH-GCP, Declaration of Helsinki, and Chinese regulations. IRB/EC approval and written informed consent are mandatory prior to initiation. Participant confidentiality is protected.
  8. Planned Timeline Site Activation \& Enrollment: Nov 2025 - Jun 2026

Treatment \& Follow-up: Through Dec 2026

Data Analysis \& Reporting: 2027

Being tested
Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets
Keywords
SGLT2 inhibitor
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Henagliflozin, Retagliptin, and Metformin Extended-Release TabletsDrug

    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.

Study groups in NCT07441187
Study groupRoleWhat they receive
treatment groupNot described
Receives: Drug: Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HbA1c from baseline to Week 24.

    Measured: Week 24

Secondary outcomes (5)
  1. Proportions achieving HbA1c targets

    Measured: week 24

  2. changes in body weight

    Measured: week 24

  3. adherence rate

    Measured: week 24

  4. systolic/diastolic blood pressure

    Measured: week 24

  5. fasting/postprandial glucose

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start20 Feb 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07441187
Sponsor's protocol ID
XHEC-C-2025-272-2
Status last verified
Feb 2026
First submitted
23 Feb 2026
Last updated
27 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of T2DM (Type 2 Diabetes Mellitus), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c from baseline to Week 24. (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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