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

Phase 1

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: liraglutide

• Registration Number: NCT01508806
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Subjects meeting the pre-defined GFR (glomerular filtration rate) criteria (estimated by the Cockcroft and Gault formula) for any of the renal function groups
• Body Mass Index (BMI) maximum 40 kg/m^2

Exclusion Criteria

• Known or suspected allergy to trial product(s) or related products
• Renal transplanted patients
• Haemodialysis patients
• Cardiac problems
• Uncontrolled treated/untreated hypertension
• History of alcoholism or drug abuse during the last 12 months
• Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
• Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator
• Excessive consumption of food deviating from a normal diet as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal renal function	liraglutide	-
Mild renal impairment	liraglutide	-
Moderate renal impairment	liraglutide	-
Severe renal impairment	liraglutide	-
End-stage renal disease	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Area under the Curve (AUC)

Secondary Outcome Measures

Name	Time	Method
AUC (0-t)
Cmax, maximum concentration
tmax, time to reach Cmax
t½, terminal half-life
CLR (renal clearance)
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇦🇺 Christchurch, Australia