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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal renal function<br> | Drug: liraglutide<br>* Single dose of 0.75 mg, administered as a subcutaneous injection<br>|
| Experimental: Mild renal impairment<br> | Drug: liraglutide<br>* Single dose of 0.75 mg, administered as a subcutaneous injection<br>|
| Experimental: Moderate renal impairment<br> | Drug: liraglutide<br>* Single dose of 0.75 mg, administered as a subcutaneous injection<br>|
| Experimental: Severe renal impairment<br> | Drug: liraglutide<br>* Single dose of 0.75 mg, administered as a subcutaneous injection<br>|
| Experimental: End-stage renal disease<br> | Drug: liraglutide<br>* Single dose of 0.75 mg, administered as a subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (AUC) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (0-t) |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| t½, terminal half-life |  |  | 
| CLR (renal clearance) |  |  | 
| Adverse events |  |  |