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

Phase 2

Recruiting

Conditions: Type 2 diabetes

Registration Number: 2023-505959-45-00

Lead Sponsor: Odense University Hospital

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruiting

Sex: Not specified

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: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in bone strength, assessed by microindentation		Change in bone strength, assessed by microindentation
Change in bone formation rate, based on dynamic histomorphometry of bone tissue		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 degradation markers Collagen I, cross-linked C-terminal telopeptide (CTX)
Change in bone formation markers osteocalcin and bone alkaline phosphatase		Change in bone formation markers osteocalcin and bone alkaline phosphatase
Change in bone mineral density, assessed by DXA scan		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 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 fat and lean tissue distribution, assessed by DXA
Change in BMI		Change in BMI
Change in HbA1c		Change in HbA1c
Change in physical activity, based on analysis of International Physical Activity Questionnaire Short Form (IPAQ-SF).		Change in physical activity, based on analysis of International Physical Activity Questionnaire Short Form (IPAQ-SF).

Trial Locations

Locations (1): Odense University Hospital
🇩🇰
Odense C, Denmark
Odense University Hospital
🇩🇰Odense C, Denmark
Morten Svarer Hansen
Site contact
+4521249531
morten.steen.hansen@rsyd.dk