Effects of Henagliflozin Proline and Metformin XR on Body Composition in Geriatric Patients With Newly Diagnosed T2DM

• Henagliflozin Proline Tablets treatment (Drug): Start with a once-daily dose of either Henagliflozin Proline Tablets (5mg) , with a potential dose adjustment at Week 12.
• Metformin XR treatment (Drug): Start with a once-daily dose of either Metformin XR (1000mg), with a potential dose adjustment at Week 12.

Primary outcomes

• Change in body composition (Appendicular Skeletal Muscle mass / Height² kg/m² weight in kilograms, height in meters) from baseline to Week 24. [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.

Secondary outcomes

• Change in appendicular skeletal muscle mass relative to body weight (ASM/BW) from baseline to Week 24. [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.
• Change in HbA1c from baseline to Week 24. [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.
• Change in body fat percentage from baseline to Week 24. [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.

Sex: All, ages: 60 Years to 85 Years

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.