Status:
COMPLETED
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01508806
Start Date
August 1 2005
End Date
March 1 2006
Last Update
January 24 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Christchurch, Australia, 2856