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

NCT07323381 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-01-07

No results posted yet for this study

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. 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.

Conditions

  • Diabetes Type 2

Interventions

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.

DRUG

Metformin XR treatment

Start with a once-daily dose of either Metformin XR (1000mg), with a potential dose adjustment at Week 12.

Sponsors & Collaborators

  • Shanxi Provincial People's Hospital

    collaborator OTHER_GOV

  • Zhongnan Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • The Second Affiliated Hospital of Shandong First Medical University

    collaborator OTHER

  • Fifth Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Bin Lu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-30
Primary Completion
2027-09-30
Completion
2027-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07323381 on ClinicalTrials.gov