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

September 25, 2018 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide
Liraglutide ("Victoza"), subcutaneous 1,8 mg once daily for 180 days
Drug: Liraglutide
Once daily
Other Names:
  • Victoza
Placebo Comparator: Placebo
Saline, subcutaneous once daily for 180 days
Drug: Placebo
Once daily
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in collagen I cross-linked C-terminal telopeptide measured in serum
Time Frame: Days 0, 7, 28, 90, 180
Collagen I cross-linked C-terminal telopeptide has been chosen as primary endpoint as the expected mechanism of action is reduction in bone resorption, and as it is the most responsive bone resorption marker.
Days 0, 7, 28, 90, 180

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in bone alkaline phosphatase measured in serum
Time Frame: Days 0, 7, 28, 90, 180
Days 0, 7, 28, 90, 180
Change in BMD evaluated by DXA
Time Frame: Days 0, 90, 180
Days 0, 90, 180
Change in bone structure evaluated by QCT and HRpQCT
Time Frame: Days 0, 90, 180
Days 0, 90, 180
Change in HbA1c
Time Frame: Days 0, 180
Days 0, 180
Change in osteocalcin measured in serum
Time Frame: Days 0, 7, 28, 90, 180
Days 0, 7, 28, 90, 180
Change in procollagen type I N-terminal propeptide measured in serum
Time Frame: Days 0, 7, 28, 90, 180
Days 0, 7, 28, 90, 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Novo Nordisk A/S
Aarhus University Hospital

Investigators

  • Study Director: Bente L Langdahl, MD PhD DMSc, Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

June 8, 2015

First Submitted That Met QC Criteria

June 12, 2015

First Posted (Estimate)

June 17, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07052015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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