Oral Semaglutide's effect on bone health in older adults with Type 2 Diabetes

The Effect of Oral Semaglutide on Bone Turnover in Patients With Type 2 Diabetes: a Randomized Placebo-controlled Clinical Trial - (SOBER II)

This study is testing if taking oral Semaglutide can help improve bone health and lower the risk of fractures in older adults with Type 2 Diabetes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Odense University Hospital (other)
• Locations: 1 site (Odense)
• Trial ID: NCT06050577 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the impact of oral Semaglutide, a GLP-1 receptor agonist, on bone turnover in patients aged 50-85 years with Type 2 Diabetes and an increased risk of fractures. Participants will receive either Semaglutide or a placebo daily for 52 weeks. The study will assess changes in bone health through blood markers, bone scans, and direct measurements of bone strength. The goal is to determine if Semaglutide can improve bone density and reduce fracture risk in this population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50-85 with Type 2 Diabetes and a T-score of less than -1, indicating osteopenia.

Not a fit: Patients with severe osteoporosis (T-score less than -2.5) or those with Type 1 Diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance bone strength and reduce fracture risk in older adults with Type 2 Diabetes.

How similar studies have performed: While the specific approach of using oral Semaglutide for bone health is novel, similar studies have shown positive effects of GLP-1 receptor agonists on metabolic health.

Eligibility criteria

Inclusion criteria

* 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

Exclusion criteria

* 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
* 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.
* Congestive heart failure (NYHA Class IV)
* Primary hyperparathyroidism
* Vitamin D deficiency (\<25 nM) (re-test after substitution acceptable)
* 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.
* History of gastrointestinal surgery (except uncomplicated surgical procedures such as hernia surgery and appendectomy)
* Antiresorptive or bone anabolic drugs for the last 12 months
* Use of anabolic steroids in the previous year
* Use of GLP-1Ras within 90 days
* Stable therapy with DPP4 inhibitors (unless the patient is willing to discontinue the treatment)
* History of pancreatitis
* Allergy or hypersensitivity to the active substance or to any of the ingredients
* Inability to give informed consent
* Previous bariatric surgery
* BMI \<20 kg/m2 or BMI\>37 kg/m2

Where this trial is running

Odense

• Odense University Hospital — Odense, Denmark (RECRUITING)

Study contacts

• Study coordinator: Julie Bjerrelund, MD

Conditions: Type 2 Diabetes, Osteopenia