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Treatment of Diabetic Neuropathy With Liraglutide (TODINELI)

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ClinicalTrials.gov Identifier: NCT02138045
Recruitment Status : Unknown
Verified January 2016 by Asbjørn Mohr Drewes, Aalborg University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : May 14, 2014
Last Update Posted : January 5, 2016
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Asbjørn Mohr Drewes, Aalborg University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Type 1 Diabetes Mellitus Drug: Placebo treatment Drug: Liraglutide treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded, Single-centre, Parallel-group, Placebo-controlled, Prospective Trial of Neuroprotective Effect of Liraglutide for Treatment of Diabetic Neuropathy.
Study Start Date : May 2014
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
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.

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

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Other Outcome Measures:
  1. HbA1C [ Time Frame: After 6 months of treatment with Liraglutide ]
  2. Biochemical lipid profile [ Time Frame: After 6 months of treatment with Liraglutide ]
  3. Heart rate and blood pressure [ Time Frame: After 6 months of treatment with Liraglutide ]
  4. Weight/body mass index [ Time Frame: After 6 months of treatment with Liraglutide ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138045


Locations
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Denmark
Mech-Sense, Department of Medical Gastroenterology, Aalborg University Hospital
Aalborg, Jutland, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Novo Nordisk A/S
Investigators
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Principal Investigator: Asbjørn M. Drewes, Professor Mech-Sense, Department of Medical Gastroenterology, Aalborg Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Asbjørn Mohr Drewes, Professor, MD, PhD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT02138045    
Other Study ID Numbers: TODINELI
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by Asbjørn Mohr Drewes, Aalborg University Hospital:
Diabetes Mellitus, Type 1
Diabetic Neuropathy
Liraglutide
Additional relevant MeSH terms:
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Diabetic Neuropathies
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists