2023-505959-45-00招募中2 期
The effect of oral Semaglutide on bone turnover in patients with T2D: a randomized placebo-controlled clinical trial (SOBER II)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Percentage change in bone formation marker procollagen type 1 N-terminal propeptide (P1NP) after 52 weeks.
研究概览
简要总结
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.
研究设计
- 分配方式
- Randomized
- 主要目的
- Study design SOBER II
- 盲法
- Double (Analyst, Investigator, Carer, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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.
- •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)
结局指标
主要结局
Percentage change in bone formation marker procollagen type 1 N-terminal propeptide (P1NP) after 52 weeks.
Percentage change in bone formation marker procollagen type 1 N-terminal propeptide (P1NP) after 52 weeks.
次要结局
- Change in bone strength, assessed by microindentation
- Change in bone formation rate, based on dynamic histomorphometry of bone tissue
- Change in bone degradation markers Collagen I, cross-linked C-terminal telopeptide (CTX)
- Change in bone formation markers osteocalcin and bone alkaline phosphatase
- Change in bone mineral density, assessed by DXA scan
- Change in trabecular and cortical volumetric bone density and estimated strength (finite element analysis), assessed using second generation high resolution peripheral quantitative CT
- Change in fat and lean tissue distribution, assessed by DXA
- Change in BMI
- Change in HbA1c
- Change in physical activity, based on analysis of International Physical Activity Questionnaire Short Form (IPAQ-SF).
研究者
Julie Bjerrelund
Scientific
Odense University Hospital
研究点 (1)
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