Diabetes Type 2Phase 4HABIT-GEMsNCT07323381
Effects of Henagliflozin Proline and Metformin XR on Body Composition in Geriatric Patients With Newly Diagnosed T2DM
A Phase 4 study testing Henagliflozin Proline Tablets treatment and Metformin XR treatment in people with Diabetes Type 2, run by Bin Lu.
Trial summary
The goal of this clinical trial is to compare the effects of Henagliflozin Proline Tablets versus Metformin Extended-Release on body composition in elderly, drug-naïve patients with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Henagliflozin Proline Tablets treatment and Metformin XR treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Sep 2027
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form, be able to understand the procedures and methods of this study, and be willing to strictly comply with the clinical trial protocol to complete the study.
- Aged between 60 and 85 years (inclusive) at the time of screening, regardless of gender.
- Diagnosed with Type 2 Diabetes Mellitus according to WHO criteria, and not having used any glucose-lowering medications in the recent 3 months.
- 7.0% ≤ HbA1c ≤ 11.0% and Fasting Plasma Glucose ≤ 15 mmol/L. Body fat percentage: ≥25% for males, ≥30% for females.
Who cannot join
- Known or suspected allergy to metformin, SGLT2 inhibitors, or excipients of the investigational product.
- History of Type 1 Diabetes or other forms of insulin-dependent diabetes. Acute metabolic complications within the past 6 months, such as ketoacidosis, lactic acidosis, or hyperosmolar coma.
- History of severe or recurrent hypoglycemic episodes. Presence of diabetes insipidus. Unstable thyroid function with treatment doses not stabilized within the past 3 months.
- History of cardiovascular events within the past 6 months. Patients with uncontrolled hypertension or hypotension. Presence of clinical symptoms or recurrent urinary tract infections or genital infections.
- History of osteoporosis, hematological diseases, malignancy, significant gastrointestinal disorders, fluid retention states, hypovolemia, or uncontrolled psychiatric disorders.
- Systemic corticosteroid therapy for more than 7 days within the past 3 months. History of bariatric surgery within the past 12 months, use of weight-control medications within the past 3 months, or current participation in a weight-loss program not in the maintenance phase.
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- Gastrointestinal surgery that affects absorption within the past 3 months; long-term use of medications directly affecting gastrointestinal motility; or acute stress conditions such as surgery, infection, or hospitalization within the past 3 months.
- Participation in any other drug clinical trial within the past 3 months. ALT or AST levels > 3 times the upper limit of normal; Hemoglobin ≤ 100 g/L; Renal impairment, defined as eGFR < 45 mL/min/1.73 m²; Fasting triglycerides ≥ 5.64 mmol/L.
- History of diabetic retinopathy. Significantly abnormal 12-lead ECG. Any other condition deemed by the investigator as unsuitable for the subject's participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Randomized, Parallel-group Clinical Study on the Effects of Henagliflozin Proline Tablets and Metformin Sustained-release Tablets on Body Composition in Geriatric Patients With Newly Diagnosed Type 2 Diabetes Mellitus
The goal of this clinical trial is to compare the effects of Henagliflozin Proline Tablets versus Metformin Extended-Release on body composition in elderly, drug-naïve patients with Type 2 Diabetes. The main questions it aims to answer are:
The effect of each treatment on the change in body composition, as measured by Appendicular Skeletal Muscle Index (ASMI), from baseline to 24 weeks.
Read more
The effect of each treatment on the change in HbA1c from baseline to 24 weeks. The comparative safety profile and other efficacy measures (e.g. fasting plasma glucose and additional body composition parameters) between the two treatments.
Researchers will compare the Henagliflozin Proline treatment group to the Metformin Extended-Release treatment group to evaluate potential differences in changes in muscle mass and metabolic parameters.
Participants will:
Be randomly assigned to one of the two treatment groups. Attend multiple clinic visits and telephone follow-ups over a 28-week period.
At clinic visits, undergo procedures including:
Physical examinations (height, weight, blood pressure, circumferences). Body composition analysis using bioelectrical impedance analysis (BIA). Physical function tests (handgrip strength, 5-times sit-to-stand test, 6-meter walk speed).
Blood and urine tests for efficacy and safety biomarkers. Dietary recording and exercise guidance. Start with a once-daily dose of either Henagliflozin Proline (5 mg) or Metformin XR (1000 mg), with a potential dose adjustment at Week 12.
- Conditions
- Diabetes Type 2
- Being tested
- Henagliflozin Proline Tablets treatment, Metformin XR treatment
- 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 Proline Tablets treatmentDrug
Start with a once-daily dose of either Henagliflozin Proline Tablets (5mg) , with a potential dose adjustment at Week 12.
Metformin XR treatmentDrug
Start with a once-daily dose of either Metformin XR (1000mg), with a potential dose adjustment at Week 12.
| Study group | Role | What they receive |
|---|---|---|
| Henagliflozin Proline Tablets treatment group | Experimental | Drug: Henagliflozin Proline Tablets treatment Start with a once-daily dose of either Henagliflozin Proline Tablets (5mg) ,with a potential dose adjustment at Week 12. Receives: Drug: Henagliflozin Proline Tablets treatment |
| Metformin Sustained-release tablets treatment group | Experimental | Start with a once-daily dose of either Metformin XR (1000mg), with a potential dose adjustment at Week 12. Receives: Drug: Metformin XR treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition (Appendicular Skeletal Muscle mass / Height² kg/m² weight in kilograms, height in meters) from baseline to Week 24.
Appendicular skeletal muscle mass index (ASMI, kg/m²) will be derived from bioelectrical impedance analysis (BIA) measurements. ASMI is calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²). ASM will be estimated using a BIA device. Measurements will be performed at baseline (V0) and at week 24 (V6), following a standardised protocol that includes ≥4 hours of fasting. The ASM value will be generated by the device's integrated software.
Measured: from baseline to Week 24
Secondary outcomes (3)
Change in appendicular skeletal muscle mass relative to body weight (ASM/BW) from baseline to Week 24.
ASM/BW is a unitless ratio (kg/kg) of appendicular skeletal muscle mass to total body weight. Both components will be measured using a bioelectrical impedance analysis (BIA) device, following a standardized protocol that includes participant fasting and rest prior to measurement. The ratio will be calculated from the raw BIA estimates of appendicular skeletal muscle mass and total body weight generated by the device software.
Measured: from baseline to Week 24
Change in HbA1c from baseline to Week 24.
HbA1c: Assessed from venous blood samples collected after a required fast. Analysis will be performed using a standardized, high-performance liquid chromatography (HPLC) method in a certified central laboratory at Baseline and Week 24.
Measured: from baseline to Week 24
Change in body fat percentage from baseline to Week 24.
Body fat percentage (BF%) is a unitless index calculated as estimated total body fat mass (in kg) divided by estimated total body weight (in kg), multiplied by 100%. Both fat mass and total body weight will be estimated by a bioelectrical impedance analysis (BIA) device, following a standardised pre-measurement protocol which includes fasting and rest.
Measured: from baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start30 Dec 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Lu
- Sponsor type
- University, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital, Zhongnan Hospital, Second Affiliated Hospital of Soochow University, The Second Affiliated Hospital of Shandong First Medical University, Fifth Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor-investigator, Bin Lu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323381
- Sponsor's protocol ID
- 2025K268
- Acronym
- HABIT-GEMs
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-group Clinical Study on the Effects of Henagliflozin Proline Tablets and Metformin Sustained-release Tablets on Body Composition in Geriatric Patients With Newly Diagnosed Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07323381
- Acronym / sponsor ID
- HABIT-GEMs / 2025K268
- Conditions
- Diabetes Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Bin LuUniversity, hospital or other
- Collaborators
- Shanxi Provincial People's Hospital, Zhongnan Hospital, Second Affiliated Hospital of Soochow University, The Second Affiliated Hospital of Shandong First Medical University, Fifth Affiliated Hospital, Sun Yat-Sen University
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Jan 2026 (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.
The goal of this clinical trial is to compare the effects of Henagliflozin Proline Tablets versus Metformin Extended-Release on body composition in elderly, drug-naïve patients with Type 2 Diabetes. The main questions it aims to answer are:
The effect of each treatment on the change in body composition, as measured by Appendicular Skeletal Muscle Index (ASMI), from baseline to 24 weeks.
The effect of each treatment on the change in HbA1c from baseline to 24 weeks. The comparative safety profile and other efficacy measures (e.g. fasting plasma glucose and additional body composition parameters) between the two treatments.
Researchers will compare the Henagliflozin Proline treatment group to the Metformin Extended-Release treatment group to evaluate potential differences in changes in muscle mass and metabolic parameters.
Participants will:
Be randomly assigned to one of the two treatment groups. Attend multiple clinic visits and telephone follow-ups over a 28-week period.
At clinic visits, undergo procedures including:
Physical examinations (height, weight, blood pressure, circumferences). Body composition analysis using bioelectrical impedance analysis (BIA). Physical function tests (handgrip strength, 5-times sit-to-stand test, 6-meter walk speed).
Blood and urine tests for efficacy and safety biomarkers. Dietary recording and exercise guidance. Start with a once-daily dose of either Henagliflozin Proline (5 mg) or Metformin XR (1000 mg), with a potential dose adjustment at Week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Henagliflozin Proline Tablets treatment group | Experimental | Drug: Henagliflozin Proline Tablets treatmentDrug: Henagliflozin Proline Tablets treatment Start with a once-daily dose of either Henagliflozin Proline Tablets (5mg) ,with a potential dose adjustment at Week 12. |
| Metformin Sustained-release tablets treatment group | Experimental | Drug: Metformin XR treatmentStart with a once-daily dose of either Metformin XR (1000mg), with a potential dose adjustment at Week 12. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form, be able to understand the procedures and methods of this study, and be willing to strictly comply with the clinical trial protocol to complete the study.
- Aged between 60 and 85 years (inclusive) at the time of screening, regardless of gender.
- Diagnosed with Type 2 Diabetes Mellitus according to WHO criteria, and not having used any glucose-lowering medications in the recent 3 months.
- 7.0% ≤ HbA1c ≤ 11.0% and Fasting Plasma Glucose ≤ 15 mmol/L. Body fat percentage: ≥25% for males, ≥30% for females.
Key exclusion criteria (9 listed)
- Known or suspected allergy to metformin, SGLT2 inhibitors, or excipients of the investigational product.
- History of Type 1 Diabetes or other forms of insulin-dependent diabetes. Acute metabolic complications within the past 6 months, such as ketoacidosis, lactic acidosis, or hyperosmolar coma.
- History of severe or recurrent hypoglycemic episodes. Presence of diabetes insipidus. Unstable thyroid function with treatment doses not stabilized within the past 3 months.
- History of cardiovascular events within the past 6 months. Patients with uncontrolled hypertension or hypotension. Presence of clinical symptoms or recurrent urinary tract infections or genital infections.
- History of osteoporosis, hematological diseases, malignancy, significant gastrointestinal disorders, fluid retention states, hypovolemia, or uncontrolled psychiatric disorders.
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 Tablets treatmentStart with a once-daily dose of either Henagliflozin Proline Tablets (5mg) , with a potential dose adjustment at Week 12. | Drug | Henagliflozin Proline Tablets treatment group |
| Metformin XR treatmentStart with a once-daily dose of either Metformin XR (1000mg), with a potential dose adjustment at Week 12. | Drug | Metformin Sustained-release tablets treatment group |
Primary outcome
Change in body composition (Appendicular Skeletal Muscle mass / Height² kg/m² weight in kilograms, height in meters) from baseline to Week 24.
Time frame: from baseline to Week 24
Appendicular skeletal muscle mass index (ASMI, kg/m²) will be derived from bioelectrical impedance analysis (BIA) measurements. ASMI is calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²). ASM will be estimated using a BIA device. Measurements will be performed at baseline (V0) and at week 24 (V6), following a standardised protocol that includes ≥4 hours of fasting. The ASM value will be generated by the device's integrated software.
3 secondary outcomes
Change in appendicular skeletal muscle mass relative to body weight (ASM/BW) from baseline to Week 24.
Time frame: from baseline to Week 24
Change in HbA1c from baseline to Week 24.
Time frame: from baseline to Week 24
Change in body fat percentage from baseline to Week 24.
Time frame: from baseline to Week 24
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 7 Jan 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Henagliflozin Proline Tablets treatment and Metformin XR treatment in people with Diabetes Type 2, run by Bin Lu.
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 9 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 7 Jan 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.
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 bin lu (+86 18121186716, lubinfd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (Appendicular Skeletal Muscle mass / Height² kg/m² weight in kilograms, height in meters) from baseline to Week 24. (time frame: from baseline to 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 7 Jan 2026.