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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Complications Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Liraglutide

Liraglutide ("Victoza"), subcutaneous 1,8 mg once daily for 180 days

Group Type EXPERIMENTAL

Liraglutide

Intervention Type DRUG

Once daily

Placebo

Saline, subcutaneous once daily for 180 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Once daily

Interventions

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Liraglutide

Once daily

Intervention Type DRUG

Placebo

Once daily

Intervention Type DRUG

Other Intervention Names

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Victoza Saline

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No