Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function

Sponsor
Novo Nordisk A/S
Study ID
NCT01508806
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Single dose of 0.75 mg, administered as a subcutaneous injection

Study Details

This trial is conducted in Oceania. The aim of this trial is to assess whether dose adjustment is required for patients with renal impairment by investigating the pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.

Key Dates

Start date
Aug 31, 2005
Status verified
Jan 2017
Primary completion
Mar 31, 2006
Completion
Mar 31, 2006

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Normal renal function
  • Experimental: Mild renal impairment
  • Experimental: Moderate renal impairment
  • Experimental: Severe renal impairment
  • Experimental: End-stage renal disease

Primary Outcome Measure

Area under the Curve (AUC)

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