NCT06050577Active, not recruitingPhase 2
The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial
The Effect of Oral Semaglutide on Bone Turnover in Patients With Type 2 Diabetes: a Randomized Placebo-controlled Clinical Trial - (SOBER II)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
The hypothesis for this study is that oral Semaglutide, a GLP-1Ra, has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 50-85 years with type 2 diabetes and an increased risk of bone fractures. Treatment involves once daily oral GLP-1Ra semaglutide or matching placebo for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue and bone marrow tests (bone marrow aspiration and biopsy), physical activity assessed by a questionnaire, and direct bone strength measured by microindentation at the start and end of the study.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 8 Sept 2023
- Start date
- 7 Jun 2024
- Primary completion date
- 15 Jan 2027
- Lead sponsor
- Odense University Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT06050577
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 7 Jun 2024 to the primary completion date, 15 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antiresorptive or bone anabolic drugs for the last 12 months
- Use of anabolic steroids in the previous year
- Stable therapy with DPP4 inhibitors (unless the patient is willing to discontinue the treatment)
- Previous bariatric surgery
Other illness
- T-score \<-2.5 in hip or lower back, assessed by DXA scan, although these individuals may be included if they are not candidates for conventional osteoporosis therapy, e.g., due to allergies and renal impairment, or if they prefer to participate in the trial.
- Type 1 diabetes mellitus
- Congestive heart failure (NYHA Class IV)
- History of gastrointestinal surgery (except uncomplicated surgical procedures such as hernia surgery and appendectomy)
- History of pancreatitis
- Allergy or hypersensitivity to the active substance or to any of the ingredients
Lab values
- Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \<30) or liver dysfunction (baseline phosphatase higher than twice upper limit (105 U/L)), rheumatism, celiac disease, hypogonadism, severe COPD, hypopituitarism, Cushing's disease
- Clinically significant concomitant diseases or disorders (e.g., cancer) or clinically significant abnormal values in laboratory screening tests, including increased Choriogonadotropin (hCG) in women.
Other
- Severe NPDR (non-proliferative diabetic retinopathy) or PDR (proliferative diabetic retinopathy) assessed within the last year. If a recent assessment is unavailable, a new retinal photo test will be performed.
- Primary hyperparathyroidism
- Vitamin D deficiency (\<25 nM) (re-test after substitution acceptable)
- Use of GLP-1Ras within 90 days
- Inability to give informed consent
- BMI \<20 kg/m2 or BMI\>37 kg/m2
Who the study is looking for
- Type 2 diabetes and glycosylated haemoglobin (HbA1C) of 48-91 mmol/mol (6.5-10.5%) and
- T-score \<+1 in hip or lower back, assessed by DXA scan and / or
- Low-energy fracture within the last 3 years
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.