New-onset Type 2 DiabetesPhase 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
A Phase 4 study testing henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) and Metformin in people with New-onset Type 2 Diabetes, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- New-onset Type 2 Diabetes
- What is being tested?
- henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2025to 30 Dec 2026
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Fei Cao, +86-17805050859, caofei1616@163.com
About this 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.
- Conditions
- New-onset Type 2 Diabetes
- Being tested
- henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ), Metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ)Drug
henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) (5mg/500mg, once a day, two tablets each time) plus lifestyle intervention
MetforminDrug
Metformin (500mg, twice a day) plus lifestyle intervention
| Study group | Role | What they receive |
|---|---|---|
| henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) | Experimental | 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 Receives: Drug: henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) |
| metformin | Active comparator | Initiation of metformin (500 mg twice a day) + lifestyle intervention Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin, Type A1C（HbA1C）
Measured: 24 weeks
Secondary outcomes (9)
Fasting blood glucose (FBG)
Measured: 4,12, 24 weeks
2-hour postprandial blood glucose (PBG)
Measured: 4,12, 24 weeks
Diabetes reversal rate
Measured: 36 weeks
fasting insulin/C-peptide and postprandial 2-hour insulin/C-peptide
Measured: 24 weeks
HbA1c
Measured: 4, 12weeks
Blood lipids (high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG])
Measured: 12, 24 weeks
blood urine acid
Measured: 12, 24 weeks
Urinary Albumin-to-Creatinine Ratio (UACR)
Measured: 12, 24 weeks
body weight
Measured: 4,12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start11 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for New-onset Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Suncadia Medicine Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888050
- Sponsor's protocol ID
- KT20240056
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06888050
- Acronym / sponsor ID
- KT20240056
- Conditions
- New-onset Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Shandong Suncadia Medicine Co., Ltd.
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) | Experimental | Drug: 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 |
| metformin | Active comparator | Drug: MetforminInitiation of metformin (500 mg twice a day) + lifestyle intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) |
| MetforminMetformin (500mg, twice a day) plus lifestyle intervention | Drug | metformin |
Primary outcome
Glycosylated Hemoglobin, Type A1C（HbA1C）
Time frame: 24 weeks
9 secondary outcomes
Fasting blood glucose (FBG)
Time frame: 4,12, 24 weeks
2-hour postprandial blood glucose (PBG)
Time frame: 4,12, 24 weeks
Diabetes reversal rate
Time frame: 36 weeks
fasting insulin/C-peptide and postprandial 2-hour insulin/C-peptide
Time frame: 24 weeks
HbA1c
Time frame: 4, 12weeks
Blood lipids (high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], triglycerides [TG])
Time frame: 12, 24 weeks
blood urine acid
Time frame: 12, 24 weeks
Urinary Albumin-to-Creatinine Ratio (UACR)
Time frame: 12, 24 weeks
body weight
Time frame: 4,12, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for New-onset Type 2 Diabetes
RecruitingPhase 1/2
A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes
Type 1 Diabetes, New Onset
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing henagliflozin proline and metformin hydrochloride extended-release tablets (Ⅰ) and Metformin in people with New-onset Type 2 Diabetes, run by Zhejiang Provincial People's Hospital at 1 site in China.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Xiaohong Wu (+86-13815870351, drxhwu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated Hemoglobin, Type A1C（HbA1C） (time frame: 24 weeks). 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 12 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.