Treatment of Diabetic Neuropathy With Liraglutide

Sponsor
Aalborg University Hospital
Study ID
NCT02138045
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo treatment — DRUG
    Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.
  • Liraglutide treatment — DRUG
    Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.

Study Details

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.

Key Dates

Start date
May 31, 2014
Status verified
Aug 2021
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017

Study Design

Enrollment
39 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

RIII withdrawal reflex activity (using standard electromyography) [ Time Frame: After 6 months of treatment with Liraglutide ]

Related Studies