The Effect of Liraglutide on Bone Turnover, Bone Mass and Bone Cell Function (LIRABONE)

University of Aarhus

Status and phase

Completed

Phase 4

Conditions

Osteoporosis

Diabetes Complications

Treatments

Drug: Liraglutide

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02473809

07052015

Details and patient eligibility

About

The purpose of this study is to test whether liraglutide, a drug approved and widely used in the treatment of type 2 diabetes, has an effect on bone mass and bone cell function. Type 2 diabetes may cause multiple complications, and it is well known that patients with type 2 diabetes have a higher risk of fractures. If Liraglutide can be demonstrated to have a positive effect on bone, this may be one among other factors to consider before the decision about specific treatment of type 2 diabetes is made for the individual patient.

Full description

Background: Type 2 diabetes may cause complications such as ischemic heart disease, nephropathy, neuropathy, and retinopathy. Several epidemiologic and animal studies also suggest that fracture risk is increased in diabetes.

Bone is remodelled throughout life through bone resorption by the bone resorbing cells, the osteoclasts, and by bone formation by the bone forming cells, the osteoblasts. Bone remodelling can be monitored by biochemical markers of bone turnover and the effect of bone remodelling can be measured by changes in bone mineral density (BMD) by Dual X-ray absorptiometry (DXA) or bone structure by quantitative CT (QCT) or high resolution peripheral QCT (HRpQCT). The remodelling activity and the balance between resorption and formation are influenced by many factors including food consumption. The gut hormone glucagon-like polypeptide 1 (GLP-1) is released in relation to food intake and reduces serum levels of glucagon, increases serum levels of insulin, and reduces blood glucose in diabetes. Liraglutide is a GLP-1 analogue and has been approved for the treatment of type 2 diabetes.

Aim: To investigate the effect of the GLP-1 analogue Liraglutide on bone turnover, bone mass, and bone structure in patients with type 2 diabetes.

Methods: The clinical study will be conducted as a randomised, double-blinded, placebo-controlled, prospective, clinical trial with comparative treatment regimes with either subcutaneous Liraglutide or subcutaneous placebo injections.

Perspectives: The project will bring new knowledge about the possible effects of GLP-1 analogues on bone turnover and structure. This is important given that type 2 diabetes deteriorates bone health and increases risk of fractures. If Liraglutide can be demonstrated to have a positive effect on bone, this may be one among other factors to consider before the decision about specific treatment of type 2 diabetes is made for the individual patient.

Enrollment

60 patients

Sex

All

Ages

30 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Informed consent
Diagnosis of type 2 diabetes (HbA1c > 48 mmol/mol)
Age older than 30 years

Exclusion criteria

Type 1 diabetes
Treatment with insulin
Body weight > 140 kg
HbA1c > 75 mmol/mol
Treatment with GLP-1 analogues, Dipeptidyl peptidase-4 inhibitors, or glitazones
Chronic kidney disease
Hepatic disease
Pancreatitis
Inflammatory bowel disease
Osteoporosis
Family or personal history of medullary thyroid carcinoma
Treatment with glucocorticoids
Hormone replacement therapy
Diabetic gastroparesis
Pregnancy or lactation