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

NCT ID: NCT07323381

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2027-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Henagliflozin Proline Tablets treatment group

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.

Group Type: EXPERIMENTAL

Henagliflozin Proline Tablets treatment

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Metformin XR treatment

Intervention Type: DRUG

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

Interventions

Henagliflozin Proline Tablets treatment

Start with a once-daily dose of either Henagliflozin Proline Tablets (5mg) , with a potential dose adjustment at Week 12.

Intervention Type: DRUG

Metformin XR treatment

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanxi Provincial People's Hospital

OTHER_GOV

Sponsor Role: collaborator

Zhongnan Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Shandong First Medical University

OTHER

Sponsor Role: collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Bin Lu

OTHER

Sponsor Role: lead

Responsible Party

Bin Lu

Principal Investigator, Director, Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

bin lu

Role: CONTACT

lubinfd@126.com

+86 18121186716

Other Identifiers

2025K268

Identifier Type: -

Identifier Source: org_study_id