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

NCT ID: NCT01508806

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-03-31

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal renal function

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Single dose of 0.75 mg, administered as a subcutaneous injection

Mild renal impairment

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Single dose of 0.75 mg, administered as a subcutaneous injection

Moderate renal impairment

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Single dose of 0.75 mg, administered as a subcutaneous injection

Severe renal impairment

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Single dose of 0.75 mg, administered as a subcutaneous injection

End-stage renal disease

Group Type: EXPERIMENTAL

liraglutide

Intervention Type: DRUG

Single dose of 0.75 mg, administered as a subcutaneous injection

Interventions

liraglutide

Single dose of 0.75 mg, administered as a subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Christchurch, , Australia

Countries

Australia

References

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.

Reference Type: RESULT

PMID: 20002084 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

NN2211-1329

Identifier Type: -

Identifier Source: org_study_id