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

NCT00976326 | Completed Phase 1

• 2 other identifiers: NN1250-19892009-009465-34
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Area under the NN1250 concentration-time curve after single-dose

  from 0 to 120 hours

Secondary Outcomes (3)

• Maximum observed NN1250 concentration after single-dose

  from 0 to 120 hours

• Renal clearance of NN1250

  from 0 to 24 hours

• Number of adverse events

  from Visit 2, Day -1 until Follow-up Visit

Study Arms (4)

A: Healthy volunteers

EXPERIMENTAL

Drug: insulin degludec

B: Subjects with mild liver impairment

EXPERIMENTAL

Drug: insulin degludec

C: Subjects with moderate liver impairment

EXPERIMENTAL

Drug: insulin degludec

D: Subjects with severe liver impairment

EXPERIMENTAL

Drug: insulin degludec

Interventions

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)

A: Healthy volunteers; B: Subjects with mild liver impairment; C: Subjects with moderate liver impairment; D: Subjects with severe liver impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Bratislava, 833 05, Slovakia

Location

Related Publications (1)

• Kupcova V, Arold G, Roepstorff C, Hojbjerre 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.

  PMID: 24277680 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

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: September 11, 2009
• First Posted: September 14, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

SL (1)