Liraglutide in Spinal Fluid

Liraglutide Blood-brain Transfer Clinical Trial

— LIRA-CSV  

Official title:

Liraglutide in Spinal Fluid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104037
• Other study ID #: H-2-2011-027
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: April 3, 2014
• Start date: January 2012

Study information

• Verified date: April 2014
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate transfer of liraglutide from blood to cerebrospinal fluid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Type 2 diabetes treated with liraglutide 1.8 mg for 1 month and 5% weight loss

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Liraglutide Blood-brain Transfer

Intervention

Procedure:
• Lumbar puncture

Locations

Country	Name	City	State
Denmark	Diabetes Research Division, Department of Medicine	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Mikkel Christensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cerebrospinal fluid concentration of liraglutide		time 60 minutes	No