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A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00976326
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE September 11, 2009
First Posted Date  ICMJE September 14, 2009
Last Update Posted Date January 20, 2017
Study Start Date  ICMJE August 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Area under the NN1250 concentration-time curve after single-dose [ Time Frame: from 0 to 120 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • Maximum observed NN1250 concentration after single-dose [ Time Frame: from 0 to 120 hours ]
  • Renal clearance of NN1250 [ Time Frame: from 0 to 24 hours ]
  • Number of adverse events [ Time Frame: from Visit 2, Day -1 until Follow-up Visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Investigating the Pharmacokinetic (Mode of Action in the Body) and Safety Profiles of NN1250 (Insulin Degludec) in Subjects With Various Degrees of Impaired Liver Function and in Subjects With Normal Liver Function
Official Title  ICMJE A Trial Investigating the Pharmacokinetic and Safety Profiles of NN1250 in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment and in Subjects With Normal Hepatic Function
Brief Summary This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the pharmacokinetic and safety profiles of NN1250 (insulin degludec) are altered to such an extent that the dose should be adjusted in subjects with impaired liver function compared to the dose for subjects with normal liver function.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Healthy
Intervention  ICMJE Drug: insulin degludec
The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)
Study Arms  ICMJE
  • Experimental: A: Healthy volunteers
    Intervention: Drug: insulin degludec
  • Experimental: B: Subjects with mild liver impairment
    Intervention: Drug: insulin degludec
  • Experimental: C: Subjects with moderate liver impairment
    Intervention: Drug: insulin degludec
  • Experimental: D: Subjects with severe liver impairment
    Intervention: Drug: insulin degludec
Publications * Kupčová V, Arold G, Roepstorff C, Højbjerre M, Klim S, Haahr H. Insulin degludec: pharmacokinetic properties in subjects with hepatic impairment. Clin Drug Investig. 2014 Feb;34(2):127-33. doi: 10.1007/s40261-013-0154-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2010)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2009)
24
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject with normal hepatic function, liver parameters within normal range. Not assessed with the Child-Pugh criteria. Or: Subject with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by Investigator
  • 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 outcome or execution except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Not able or willing to refrain from smoking during the inpatient period
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976326
Other Study ID Numbers  ICMJE NN1250-1989
2009-009465-34 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP