A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

Healthy Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006057
• Other study ID #: NN1250-1990
• Secondary ID: 2009-009466-14U1
• Status: Completed
• Phase: Phase 1
• First received: October 30, 2009
• Last updated: January 19, 2017
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)

• Body mass index maximum 40.0 kg/m^2

Exclusion Criteria:

• Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening

• Significant history of alcoholism or drug/chemical abuse

• Not able or willing to refrain from smoking during the inpatient period

Related Conditions & MeSH terms

• Diabetes
• Healthy
• Renal Insufficiency

Intervention

Drug:
• insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease
• insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment
• insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment
• insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers
• insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment

Locations

Country	Name	City	State
Hungary	Novo Nordisk Investigational Site	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Kiss I, Arold G, Roepstorff C, Bøttcher SG, Klim S, Haahr H. Insulin degludec: pharmacokinetics in patients with renal impairment. Clin Pharmacokinet. 2014 Feb;53(2):175-83. doi: 10.1007/s40262-013-0113-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin degludec concentration-time curve		from 0 to 120 hours after trial product administration
Secondary	Maximum observed insulin degludec concentration		from 0 to 120 hours after trial product administration
Secondary	Renal clearance of insulin degludec after single-dose		from 0 to 24 hours after trial product administration

External Links

•   Clinical Trials at Novo Nordisk