Skip to content

Trial · Interventional

CompletedNot applicableRegistry data

Treatment of Diabetic Neuropathy With Liraglutide

Short name TODINELI

Overview

Status
Completed
Phase
Not applicable
Enrollment
39 participants (actual)
Sponsor
Aalborg University Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

Denmark

Start
May 2014
Primary completion
Feb 2017
Completion
Feb 2017
First posted
14 May 2014 (estimated)
Last update posted
10 Aug 2021
Conditions
Diabetes Mellitus, Type 1 · Type 1 Diabetes Mellitus

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015201620172018
  1. N/A

    TODINELI

    NCT02138045

    May 2014 to Feb 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Placebo treatmentDrug
  • Liraglutide treatmentDrug

Arms2

  • Placebo comparator

    Placebo treatment

    Placebo 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.

  • Active comparator

    Liraglutide treatment

    Liraglutide 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. RIII withdrawal reflex activity (using standard electromyography)

    Time frame · After 6 months of treatment with Liraglutide

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

    Time frame · After 6 months of treatment with Liraglutide

Secondary outcomes(11)
  1. Heart rate variability/ alterations in simpatico-vagal balance (24 h Holter monitoring)

    Time frame · After 6 months of treatment with Liraglutide

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

    Time frame · After 6 months of treatment with Liraglutide

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

    Time frame · After 6 months of treatment with Liraglutide

  4. Variety in day/night blood pressure

    Time frame · After 6 months of treatment with Liraglutide

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

    Time frame · After 6 months of treatment with Liraglutide

  6. Quantitive sensory testing of pressure algometry in muscle

    Time frame · After 6 months of treatment with Liraglutide

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

    Time frame · 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.

    Time frame · After 6 months of treatment with Liraglutide

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

    Time frame · 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))

    Time frame · After 6 months of treatment with Liraglutide

  11. OCT

    Time frame · After 6 months of treatment with Liraglutide

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2022

4 results

Liraglutide Treatment Does Not Induce Changes in the Peripapillary Retinal Nerve Fiber Layer Thickness in Patients with Diabetic Retinopathy.

Arendt Nielsen et al. 2022Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeuticscited by 3

PMID 34918951DOI 10.1089/jop.2021.0055PUB-34918951

Full text at the publisher4 results

Indexing hint: Randomized controlled trial · 2019

7 results

Liraglutide treatment reduced interleukin-6 in adults with type 1 diabetes but did not improve established autonomic or polyneuropathy.

Brock et al. 2019British journal of clinical pharmacologycited by 82

PMID 31338868PMC6848951DOI 10.1111/bcp.14063PUB-31338868

Free to read · publisher termsCC BY-NC7 results

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedNissen 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. PMID 32571684
  • DerivedNedergaard 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. PMID 32501945

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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. * 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.