Treatment of Diabetic Neuropathy With Liraglutide (TODINELI)

Aalborg University Hospital

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Type 1 Diabetes Mellitus

Treatments: Drug: Liraglutide treatment; Drug: Placebo treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02138045

TODINELI

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

Placebo treatment

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo treatment

Liraglutide treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Liraglutide treatment