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.
None
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Parallel
Henagliflozin Proline Tablets treatment
DrugStart with a once-daily dose of either Henagliflozin Proline Tablets (5mg) , with a potential dose adjustment at Week 12.
Metformin XR treatment
DrugStart with a once-daily dose of either Metformin XR (1000mg), with a potential dose adjustment at Week 12.
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.
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.
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.
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.
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Bin Lu
Lead sponsor
Fudan University
Sponsor institution
Shanxi Provincial People's Hospital
Collaborator
Zhongnan Hospital
Collaborator
Second Affiliated Hospital of Soochow University
Collaborator
The Second Affiliated Hospital of Shandong First Medical University
Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborator
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