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NCT Number: NCT00976326

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 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Bratislava, 833 05, Slovakia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

The dose level will be one single dose of 0.4 units per kg body weight injected s.c. (subcutaneously, under the skin)

Primary outcomes

  1. Area under the NN1250 concentration-time curve after single-dose

    Time frame: from 0 to 120 hours

Secondary outcomes

  1. Maximum observed NN1250 concentration after single-dose

    Time frame: from 0 to 120 hours

  2. Renal clearance of NN1250

    Time frame: from 0 to 24 hours

  3. Number of adverse events

    Time frame: from Visit 2, Day -1 until Follow-up Visit

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2009
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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