The effect of oral Semaglutide on bone turnover in patients with T2D: a randomized placebo-controlled clinical trial (SOBER II)

Phase 1

Recruiting

• Conditions: Type 2 diabetes; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-505959-45-00
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

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., 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified