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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01508806

NN2211-1329

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Normal renal function

Experimental group

Treatment:

Drug: liraglutide

Mild renal impairment

Experimental group

Treatment:

Drug: liraglutide

Moderate renal impairment

Experimental group

Treatment:

Drug: liraglutide

Severe renal impairment

Experimental group

Treatment:

Drug: liraglutide

End-stage renal disease

Experimental group

Treatment:

Drug: liraglutide