The Effect of Oral Semaglutide on Bone Turnover in Patients With T2D: a Randomized Placebo-controlled Clinical Trial

Launched by ODENSE UNIVERSITY HOSPITAL · Sep 21, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called oral Semaglutide on bone health in people aged 50 to 85 who have type 2 diabetes and are at risk for weak bones (a condition known as osteopenia). The study aims to find out if taking Semaglutide can help improve the balance of bone building and breakdown, which is important for preventing fractures. Participants will take either Semaglutide or a placebo (a pill with no active medication) once a day for a year. Researchers will measure changes in bone health through blood tests, bone scans, and assessments of physical activity and bone strength.

To join the study, participants must have type 2 diabetes and specific blood sugar levels, as well as a certain level of bone density assessed by a scan. Key exclusion criteria include having more severe bone loss or other serious health conditions. Those who participate can expect regular check-ups and tests to monitor their bone health throughout the year. This trial is looking for individuals who are willing and able to provide informed consent and are not currently taking specific medications that could interfere with the study.

Gender

ALL

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