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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Single-centre, Open-label, Trial Investigating the Pharmacokinetics and the Tolerability of Liraglutide in Subjects With Normal Renal Function and in Subjects With Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508806
• Other study ID #: NN2211-1329
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: January 23, 2017
• Start date: August 2005
• Est. completion date: March 2006

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Single dose of 0.75 mg, administered as a subcutaneous injection

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Christchurch

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Australia, 

References & Publications (1)

Jacobsen LV, Hindsberger C, Robson R, Zdravkovic M. Effect of renal impairment on the pharmacokinetics of the GLP-1 analogue liraglutide. Br J Clin Pharmacol. 2009 Dec;68(6):898-905. doi: 10.1111/j.1365-2125.2009.03536.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Curve (AUC)
Secondary	AUC (0-t)
Secondary	Cmax, maximum concentration
Secondary	tmax, time to reach Cmax
Secondary	t½, terminal half-life
Secondary	CLR (renal clearance)
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk