Treatment of diabetic neuropathy with liraglutide

Phase 1

• Conditions: TODINELI TrialA randomized, double-blinded, single-centre, parallel-group, placebo-controlled, prospective trial of the neuroprotective effect of Liraglutide for treatment of diabetic neuropathy in Diabets mellitus type I patients; MedDRA version: 17.0Level: LLTClassification code 10012685Term: Diabetic polyneuropathySystem Organ Class: 100000004852; MedDRA version: 17.0Level: LLTClassification code 10012682Term: Diabetic peripheral autonomic neuropathySystem Organ Class: 100000004852; MedDRA version: 17.0Level: LLTClassification code 10012683Term: Diabetic peripheral neuropathySystem Organ Class: 100000004852; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2013-004375-12-DK
• Lead Sponsor: Center of Mech-Sense

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-13
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1) Habile person of Northern European descent
2) Age between 18 to 65 years
3) A verified diagnosis of DM type I for minimum 2 years
4) Stable DM treatment for minimum 3 months prior to screening
5) The participants must be able to read and understand Danish.
6) Peripheral diabetic neuropathy ensured by having abnorm nerve conduction velocity
7) BMI equal to or above 22
8) Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
9) Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Estimated glomerular filtration rate (s-creatinin/eGFR ) < 60 ml/min/1.37m2
2) Calcitonin > 25)
3) HbA1c level < 7%
4) 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.
5) Patients on GLP-1 receptor agonist treatment (exenatide, liraglutide or others) or pramlintide or any DPP-4 inhibitor within 3 months prior to screening.
6) Other neurological and/or psychiatric disease
7) Treatment of other endocrinological disease except hypothyreosis
8) Malignant neoplasms requiring chemotherapy, surgery, radiation or palliative care in the previous 5 years.
9) Family or personal history of multiple endocrine neoplasis type 2 (MEN2) or familial medullary thyroid carcinoma
10) Personal history of non-familial medullary thyroid carcinoma
11) Known abuse of alcohol and/or medicine (Alcohol use in accordance with the recommendations by the Danish Health and Medicines Authority are allowed).
12) Known allergy to liraglutide
13) Participation in other clinical trials less than 3 months prior to inclusion
14) Female patients who are pregnant or lactating, or intend to become pregnant and male patients who intend to father a child during the course of the study.
15) 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. The following methods are considered as safe contraception methods:
a. The combined oral contraceptive pill
b. Intra uterine device
c. Gestagen injection
d. Subdermal implantation
e. Hormone vaginal ring
f. Transdermal plaster

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified