This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment
Novo Nordisk Investigational Site
Budapest, Hungary
Area under the insulin degludec concentration-time curve
Time frame: from 0 to 120 hours after trial product administration
Maximum observed insulin degludec concentration
Time frame: from 0 to 120 hours after trial product administration
Renal clearance of insulin degludec after single-dose
Time frame: from 0 to 24 hours after trial product administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment