Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2025-09-15
2026-12-31
Brief Summary
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The investigators will compare semaglutide combined with metformin to metformin alone to see if semaglutide treatment has effects on bone mineral density and bone turnover markers in patients with type 2 diabetes after 12 months.
The intervention group will receive semaglutide combined with metformin for 12 months, while the control group will receive metformin alone for the same duration. After 12 months of treatment, the investigators will compare the bone mineral density, fracture incidence, and levels of bone turnover markers between the two groups.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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The intervention group
In the intervention group, the participants will receive semaglutide combined with metformin treatment.
semaglutide combined with metformin
The initial dose of semaglutide is 0.25 mg once weekly. After 4 weeks, the dose is adjusted to 0.5 mg once weekly. After another 4 weeks, the dose is adjusted to 1 mg once weekly. During the same period, they will take metformin (500mg each time, three times a day) for treatment. The treatment course is 12 months.
The control group
In the control group, the participants will be treated with metformin alone (500mg each time, three times a day).
No interventions assigned to this group
Interventions
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semaglutide combined with metformin
The initial dose of semaglutide is 0.25 mg once weekly. After 4 weeks, the dose is adjusted to 0.5 mg once weekly. After another 4 weeks, the dose is adjusted to 1 mg once weekly. During the same period, they will take metformin (500mg each time, three times a day) for treatment. The treatment course is 12 months.
Eligibility Criteria
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Inclusion Criteria
2. Age range: 50 to ≦75 years,
3. Glycosylated hemoglobin (HbA1c): 6.5 to ≦9.0%,
4. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \< -1, or history of fragility fractures (hip, vertebral, distal forearm, or proximal humerus fractures) within three years before screening,
5. No use of antidiabetic medications in 8 weeks prior to enrollment (excluding metformin).
Exclusion Criteria
2. History of secondary osteoporosis,
3. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 2.5 times the upper limit of the normal reference, or estimated glomerular filtration rate (eGFR) \< 45 ml/min/1.73㎡),
4. History of malignant tumors,
5. Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years,
6. History of pancreatitis or triglyceride levels \>5.6 mmol/L;
7. Family history of medullary carcinoma.
50 Years
75 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Shanghai Punan Hospital of Pudong New District
OTHER
Shanghai 6th People's Hospital
OTHER
Jinzhou Medical University
OTHER
The First Affiliated Hospital of Xiamen University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Countries
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Central Contacts
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Other Identifiers
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KYLLPJ2025-033
Identifier Type: -
Identifier Source: org_study_id
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