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The effect of oral Semaglutide on bone turnover in patients with T2D: a randomized placebo-controlled clinical trial (SOBER II)
EU CTIS ID: 2023-505959-45-00
What this study is testing
The aim of this trial is to investigate if semaglutide a long-acting GLP-1RA, improves bone formation and strength in men and women with type 2 diabetes and either normal or low bone mass.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Type 2 diabetes and glycosylated haemoglobin (HbA1C) of 44-91 mmol/mol (6.2-10.5%) and
- T-score </=+1 in hip or lower back, assessed by DXA scan and / or
- Low-energy fracture within the last 3 years
You likely can't join if
- 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.
- 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
See the full eligibility criteria
- Type 2 diabetes and glycosylated haemoglobin (HbA1C) of 44-91 mmol/mol (6.2-10.5%) and
- T-score </=+1 in hip or lower back, assessed by DXA scan and / or
- Low-energy fracture within the last 3 years
- 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.
- 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
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.