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Diabetes Mellitus, Type 1TODINELINCT02138045

Treatment of Diabetic Neuropathy With Liraglutide

A study testing Liraglutide treatment in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus, run by Aalborg University Hospital 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 trial is to explore whether liraglutide has a long term effect on clinical symptoms and biomarkers in patients with diabetic neuropathy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Liraglutide treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteDenmark
Study dates
May 2014to Feb 2017
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Abile person of Northern European descent
  • Age between 18 to 65 years
  • A verified diagnosis of DM type 1 for minimum 2 years (HbA1C=7%)
  • Stable DM treatment (Treatment is considered stable when the patient has been treated with basal-bolus insulin, premixed insulin or continously infused insulin with an insulin dose considered stable by investigator for at least 3 months prior to screening.)
  • The participants must be able to read and understand Danish.
  • Peripheral diabetic neuropathy ensured by having abnormal nerve conduction velocity
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  • BMI equal to or above 22
  • Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
  • Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.

Who cannot join

  • Diabetes mellitus type II
  • Estimated glomerular filtration rate (s-creatinin/eGRF) < 60 ml/min/1.37m2
  • Calcitonin > 25
  • HbA1c level < 7%
  • Patients with any clinically significant laboratory abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
  • Patients on GLP-1 receptor agonist treatment (exenatide, liraglutide or others) or pramlintide or any DPP-4 inhibitor within 3 months prior to screening.
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  • Other neurological and/or psychiatric disease
  • Treatment of other endocrinological disease except hypothyreosis
  • Malignant neoplasms requiring chemotherapy, surgery, radiation or palliative care in the previous 5 years.
  • Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma.
  • Personal history of non-familial medullary thyroid carcinoma
  • Known abuse or alcohol and/or medicine (Alcohol use in accordance with the recommendations by the Danish Health and Medicines Authority are allowed).
  • Known allergy to liraglutide.
  • Participation in other clinical trials less than 3 months prior to inclusion
  • Female patients who are pregnant or lactating, or intend to become pregnant and male patients who intend to father a child during course of the study.
  • In women, a serum pregnancy test will be conducted at baseline based on h-CG in the blood. The investigator will have to ensure that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study medication period.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital

    Aalborg, Jutland, 9000

Other trials in Denmark

About this study

Official title: A Randomized, Double-blinded, Single-centre, Parallel-group, Placebo-controlled, Prospective Trial of Neuroprotective Effect of Liraglutide for Treatment of Diabetic Neuropathy.

The purpose of this trial is to explore whether liraglutide has a long term effect on clinical symptoms and biomarkers in patients with diabetic neuropathy.

Being tested
Placebo treatment, Liraglutide treatment
Keywords
Diabetes Mellitus, Type 1, Diabetic Neuropathy, Liraglutide
Medical subject headings
Diabetes Mellitus, Type 1, Diabetic Neuropathies

What participants receive

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

  • Placebo treatmentDrug

    Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.

  • Liraglutide treatmentDrug

    Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.

Study groups in NCT02138045
Study groupRoleWhat they receive
Placebo treatmentPlacebo comparatorPlacebo solution will be slowly titrated to maximum tolerable dose in order to minimize potential side-effects, hence treatment will follow: First and second week: 0.6 mg/day; Third and fourth week: 1.2 mg/day and Fifth and to sixth week: 1.8 mg/day.
Receives: Drug: Placebo treatment
Liraglutide treatmentActive comparatorLiraglutide will be slowly titrated to maximum tolerable dose in order to minimize potential side-effects, hence treatment will follow: First and second week: 0.6 mg/day; Third and fourth week: 1.2 mg/day and Fifth and to sixth week: 1.8 mg/day.
Receives: Drug: Liraglutide treatment

What is being measured

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

  1. RIII withdrawal reflex activity (using standard electromyography)

    Measured: After 6 months of treatment with Liraglutide

  2. Evoked brain potentials (using standard electroencephalographic brain imaging).

    Measured: After 6 months of treatment with Liraglutide

Secondary outcomes (11)

  1. Heart rate variability/ alterations in simpatico-vagal balance (24 h Holter monitoring)

    Measured: After 6 months of treatment with Liraglutide

  2. Resting brain activity (spectral analysis of resting brain activity)

    Measured: After 6 months of treatment with Liraglutide

  3. Microstructural brain neurodegeneration (assessed by diffuse tensor imaging)

    Measured: After 6 months of treatment with Liraglutide

  4. Variety in day/night blood pressure

    Measured: After 6 months of treatment with Liraglutide

  5. Gut transit assessed by SmartPill (pH, pressure and transit in stomach, small and large intestine)

    Measured: After 6 months of treatment with Liraglutide

  6. Quantitive sensory testing of pressure algometry in muscle

    Measured: After 6 months of treatment with Liraglutide

  7. Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec)

    Measured: After 6 months of treatment with Liraglutide

  8. Profile of inflammatory cytokines including IL-beta, TNF-alfa, IL6, MCP-1 and specific markers sCD163, sMR, neopterin and HO-1.

    Measured: After 6 months of treatment with Liraglutide

  9. Metabolic risk factors expressed as adipokines (adiponectin, leptin, resistin) and inflammatory cell markers

    Measured: After 6 months of treatment with Liraglutide

  10. Self assessed symptomatology (Michigan neuropathy screening tool, Quality of life (SF-36), Pain catastrophizing scale (PCS) and self-assessed gastro-intestinal symptoms (PAGI-SYM))

    Measured: After 6 months of treatment with Liraglutide

  11. OCT

    Measured: After 6 months of treatment with Liraglutide

Timeline

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

  1. First posted14 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionFeb 2017
  4. Study completionFeb 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02138045
Sponsor's protocol ID
TODINELI
Acronym
TODINELI
Status last verified
Aug 2021
First submitted
13 May 2014
Last updated
10 Aug 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Arendt Nielsen T, Sega R, Uggerhoj Andersen C, Vorum H, Drewes AM, Jakobsen PE, Brock B, Brock C. Liraglutide Treatment Does Not Induce Changes in the Peripapillary Retinal Nerve Fiber Layer Thickness in Patients with Diabetic Retinopathy. J Ocul Pharmacol Ther. 2022 Jan-Feb;38(1):114-121. doi: 10.1089/jop.2021.0055. Epub 2021 Dec 16.

    PubMed 34918951

  • Nissen TD, Meldgaard T, Nedergaard RW, Juhl AH, Jakobsen PE, Karmisholt J, Drewes AM, Brock B, Brock C. Peripheral, synaptic and central neuronal transmission is affected in type 1 diabetes. J Diabetes Complications. 2020 Sep;34(9):107614. doi: 10.1016/j.jdiacomp.2020.107614. Epub 2020 May 8.

    PubMed 32571684

  • Nedergaard RB, Nissen TD, Morch CD, Meldgaard T, Juhl AH, Jakobsen PE, Karmisholt J, Brock B, Drewes AM, Brock C. Diabetic Neuropathy Influences Control of Spinal Mechanisms. J Clin Neurophysiol. 2021 Jul 1;38(4):299-305. doi: 10.1097/WNP.0000000000000691.

    PubMed 32501945

  • Brock C, Hansen CS, Karmisholt J, Moller HJ, Juhl A, Farmer AD, Drewes AM, Riahi S, Lervang HH, Jakobsen PE, Brock B. Liraglutide treatment reduced interleukin-6 in adults with type 1 diabetes but did not improve established autonomic or polyneuropathy. Br J Clin Pharmacol. 2019 Nov;85(11):2512-2523. doi: 10.1111/bcp.14063. Epub 2019 Aug 30.

    PubMed 31338868

Questions about this trial

What is this clinical trial studying?

A study testing Liraglutide treatment in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes Mellitus, run by Aalborg University Hospital 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 9 inclusion and 16 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 10 Aug 2021. 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.

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?

RIII withdrawal reflex activity (using standard electromyography) (time frame: After 6 months of treatment with Liraglutide). The study lists 2 primary outcomes in all. 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 NCT02138045, which also lists 4 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 10 Aug 2021.

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