TODINELI

CompletedPhase NA

Treatment of Diabetic Neuropathy With Liraglutide

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

Lead sponsor

Aalborg University Hospital

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Diabetic neuropathy, Type 1 diabetes

Key I/E criterion

•BMI ≥22

Primary endpoints

•RIII withdrawal reflex activity•Evoked brain potentials

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02138045

Org study IDTODINELI

Timeline

Milestones

Study first posted2014-05-14estimated

Last update posted2021-08-10actual

Study start2014-05 (month precision)

Primary completion2017-02actual (month precision)

Study completion2017-02actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Diabetic neuropathyType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers

Other clinical outcomes

Other (unclassified)

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

1 endpoint

Other/protocol endpoint/low confidence

Weight/body mass index

Time frame:After 6 months of treatment with Liraglutide

descriptive, improvement

Glycemic / diabetes

1 endpoint

Other/protocol endpoint

HbA1C

Time frame:After 6 months of treatment with Liraglutide

descriptive, improvement

LOINC 4548-4

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

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

Time frame:After 6 months of treatment with Liraglutide

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Variety in day/night blood pressure

Time frame:After 6 months of treatment with Liraglutide

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:After 6 months of treatment with Liraglutide

Adiponectin, change

change from baseline, improvement

Other/protocol endpoint/low confidence

Biochemical lipid profile

Time frame:After 6 months of treatment with Liraglutide

change from baseline, improvement

Other/protocol endpoint

Heart rate and blood pressure

Time frame:After 6 months of treatment with Liraglutide

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint/low confidence

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

SF-36 total

descriptive, improvement

componentsSF-36 total, PGI, change

Other clinical outcomes

5 endpoints

Primary/protocol endpoint/low confidence

RIII withdrawal reflex activity (using standard electromyography)

Time frame:After 6 months of treatment with Liraglutide

descriptive

Secondary/protocol endpoint/low confidence

Microstructural brain neurodegeneration (assessed by diffuse tensor imaging)

Time frame:After 6 months of treatment with Liraglutide

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:After 6 months of treatment with Liraglutide

descriptive

Secondary/protocol endpoint

Quantitive sensory testing of pressure algometry in muscle

Time frame:After 6 months of treatment with Liraglutide

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:After 6 months of treatment with Liraglutide

change from baseline, improvement

Other (unclassified)

4 endpoints

Primary/protocol endpoint/low confidence

Evoked brain potentials (using standard electroencephalographic brain imaging).

Time frame:After 6 months of treatment with Liraglutide

descriptive

Secondary/protocol endpoint/low confidence

Resting brain activity (spectral analysis of resting brain activity)

Time frame:After 6 months of treatment with Liraglutide

descriptive

Secondary/protocol endpoint/low confidence

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

descriptive

Secondary/protocol endpoint/low confidence

OCT

Time frame:After 6 months of treatment with Liraglutide

descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Liraglutide Treatment Does Not Induce Changes in the Peripapillary Retinal Nerve Fiber Layer Thickness in Patients with Diabetic Retinopathy.
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics2022 Jan-Feb (year)PMID34918951doi:10.1089/jop.2021.0055via clinicaltrials gov reference derived + pubmed nct search
Diabetic Neuropathy Influences Control of Spinal Mechanisms.
Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society2021 Jul 1PMID32501945doi:10.1097/WNP.0000000000000691via clinicaltrials gov reference derived + pubmed nct search
Peripheral, synaptic and central neuronal transmission is affected in type 1 diabetes.
Journal of diabetes and its complications2020 Sep (month)PMID32571684doi:10.1016/j.jdiacomp.2020.107614via clinicaltrials gov reference derived + pubmed nct search
Liraglutide treatment reduced interleukin-6 in adults with type 1 diabetes but did not improve established autonomic or polyneuropathy.
British journal of clinical pharmacology2019 Nov (month)PMID31338868doi:10.1111/bcp.14063via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.