NCT06050577进行中（未招募）2 期
The Effect of Oral Semaglutide on Bone Turnover in Patients With Type 2 Diabetes: a Randomized Placebo-controlled Clinical Trial - (SOBER II)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Procollagen type 1 N-terminal propeptide (P1NP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
oral Semaglutide/Rybelsus
Experimental
oral Semaglutide 7-14 mg (or highest tolerated dose) once daily for 52 weeks (incl. titration)
干预措施: oral Semaglutide/Rybelsus (Drug)
oral Placebo
Placebo Comparator
oral Placebo 7-14 mg (or highest tolerated dose) once daily for 52 weeks (incl. titration)
干预措施: Placebo (Drug)
结局指标
主要结局
Procollagen type 1 N-terminal propeptide (P1NP)
时间窗: Baseline and 52 weeks
Percentage changes in bone formation marker P1NP from baseline and after 12 months
次要结局
- Collagen 1 cross link C-terminal telopeptide (CTX)(Baseline and 52 weeks)
- Osteocalcin(Baseline and 52 weeks)
- Bone specific alkaline phosphatase (BALP)(Baseline and 52 weeks)
- Bone mineral density (BMD)(Baseline and 52 weeks)
- Estimated bone strength(Baseline and 52 weeks)
- Cortical porosity(Baseline and 52 weeks)
- Bone formation rate(52 weeks)
- Lean tissue distribution(Baseline and 52 weeks)
- Glycosylated haemoglobin (HbA1C)(Baseline and 52 weeks)
- Physical activity(Baseline and 52 weeks)
- Total volumetric BMD(Baseline and 52 weeks)
- Trabecular thickness(Baseline and 52 weeks)
- Cortical thickness(Baseline and 52 weeks)
- Trabecular volumetric BMD(Baseline and 52 weeks)
- Cortical volumetric BMD(Baseline and 52 weeks)
- Bone volume(Baseline and 52 weeks)
- Fat tissue distribution(Baseline and 52 weeks)
- Body mass index (BMI)(Baseline and 52 weeks)
研究者
研究点 (1)
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