A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function
A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function
3 other identifiers
interventional
32
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedFirst Posted
Study publicly available on registry
November 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedJanuary 20, 2017
January 1, 2017
6 months
October 30, 2009
January 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Area under the insulin degludec concentration-time curve
from 0 to 120 hours after trial product administration
Secondary Outcomes (2)
Maximum observed insulin degludec concentration
from 0 to 120 hours after trial product administration
Renal clearance of insulin degludec after single-dose
from 0 to 24 hours after trial product administration
Study Arms (5)
ESRD
EXPERIMENTALMild
EXPERIMENTALModerate
EXPERIMENTALNormal
EXPERIMENTALSevere
EXPERIMENTALInterventions
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Budapest, 1115, Hungary
Related Publications (1)
Kiss I, Arold G, Roepstorff C, Bottcher 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.
PMID: 24163264RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2009
First Posted
November 2, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
January 20, 2017
Record last verified: 2017-01