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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00976326
First received: September 11, 2009
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Healthy
Drug: insulin degludec
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the NN1250 concentration-time curve after single-dose [ Time Frame: from 0 to 120 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed NN1250 concentration after single-dose [ Time Frame: from 0 to 120 hours ] [ Designated as safety issue: No ]
  • Renal clearance of NN1250 [ Time Frame: from 0 to 24 hours ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: from Visit 2, Day -1 until Follow-up Visit ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: Healthy volunteers 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)
Experimental: B: Subjects with mild liver impairment 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)
Experimental: C: Subjects with moderate liver impairment 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)
Experimental: D: Subjects with severe liver impairment 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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976326

Locations
Slovakia
Bratislava, Slovakia, 833 05
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Marianne Thrane, MSc., PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00976326     History of Changes
Other Study ID Numbers: NN1250-1989, 2009-009465-34
Study First Received: September 11, 2009
Last Updated: October 24, 2013
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014