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Diabetes ComplicationsPhase 4LIRABONENCT02473809

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

A Phase 4 study testing Liraglutide in people with Diabetes Complications and Osteoporosis, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 30 to 90 years
Conditions the study is for
Diabetes Complications, Osteoporosis
What is being tested?
Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteDenmark
Study dates
Aug 2015to Oct 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Endocrinology and Internal Medicine, Aarhus University Hospital

    Aarhus, Aarhus C, 8000

Other trials in Denmark

About this study

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.

Read the 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.

Being tested
Liraglutide, Placebo
Medical subject headings
Diabetes Complications, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Victoza

    Once daily

  • PlaceboDrug

    Also called Saline

    Once daily

Study groups in NCT02473809
Study groupRoleWhat they receive
LiraglutideExperimentalLiraglutide ("Victoza"), subcutaneous 1,8 mg once daily for 180 days
Receives: Drug: Liraglutide
PlaceboPlacebo comparatorSaline, subcutaneous once daily for 180 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in collagen I cross-linked C-terminal telopeptide measured in serum

    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.

    Measured: Days 0, 7, 28, 90, 180

Secondary outcomes (6)

  1. Change in bone alkaline phosphatase measured in serum

    Measured: Days 0, 7, 28, 90, 180

  2. Change in BMD evaluated by DXA

    Measured: Days 0, 90, 180

  3. Change in bone structure evaluated by QCT and HRpQCT

    Measured: Days 0, 90, 180

  4. Change in HbA1c

    Measured: Days 0, 180

  5. Change in osteocalcin measured in serum

    Measured: Days 0, 7, 28, 90, 180

  6. Change in procollagen type I N-terminal propeptide measured in serum

    Measured: Days 0, 7, 28, 90, 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionOct 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473809
Sponsor's protocol ID
07052015
Acronym
LIRABONE
Status last verified
Sep 2018
First submitted
8 Jun 2015
Last updated
26 Sep 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Fehmann HC, Hering BJ, Wolf MJ, Brandhorst H, Brandhorst D, Bretzel RG, Federlin K, Goke B. The effects of glucagon-like peptide-I (GLP-I) on hormone secretion from isolated human pancreatic islets. Pancreas. 1995 Aug;11(2):196-200. doi: 10.1097/00006676-199508000-00014.

    PubMed 7479679

  • Leslie WD, Rubin MR, Schwartz AV, Kanis JA. Type 2 diabetes and bone. J Bone Miner Res. 2012 Nov;27(11):2231-7. doi: 10.1002/jbmr.1759. Epub 2012 Sep 28.

    PubMed 23023946

  • Schwartz AV, Sellmeyer DE. Diabetes, fracture, and bone fragility. Curr Osteoporos Rep. 2007 Sep;5(3):105-11. doi: 10.1007/s11914-007-0025-x.

    PubMed 17925191

  • Vestergaard P. Discrepancies in bone mineral density and fracture risk in patients with type 1 and type 2 diabetes--a meta-analysis. Osteoporos Int. 2007 Apr;18(4):427-44. doi: 10.1007/s00198-006-0253-4. Epub 2006 Oct 27.

    PubMed 17068657

  • Yamada C, Yamada Y, Tsukiyama K, Yamada K, Udagawa N, Takahashi N, Tanaka K, Drucker DJ, Seino Y, Inagaki N. The murine glucagon-like peptide-1 receptor is essential for control of bone resorption. Endocrinology. 2008 Feb;149(2):574-9. doi: 10.1210/en.2007-1292. Epub 2007 Nov 26.

    PubMed 18039776

  • Nuche-Berenguer B, Lozano D, Gutierrez-Rojas I, Moreno P, Marinoso ML, Esbrit P, Villanueva-Penacarrillo ML. GLP-1 and exendin-4 can reverse hyperlipidic-related osteopenia. J Endocrinol. 2011 May;209(2):203-10. doi: 10.1530/JOE-11-0015. Epub 2011 Mar 3.

    PubMed 21372151

  • Su B, Sheng H, Zhang M, Bu L, Yang P, Li L, Li F, Sheng C, Han Y, Qu S, Wang J. Risk of bone fractures associated with glucagon-like peptide-1 receptor agonists' treatment: a meta-analysis of randomized controlled trials. Endocrine. 2015 Feb;48(1):107-15. doi: 10.1007/s12020-014-0361-4. Epub 2014 Jul 30.

    PubMed 25074632

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide in people with Diabetes Complications and Osteoporosis, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in collagen I cross-linked C-terminal telopeptide measured in serum (time frame: Days 0, 7, 28, 90, 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02473809, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.

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