NCT01623375

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

2 months

First QC Date

June 4, 2012

Last Update Submit

February 18, 2015

Conditions

DiabetesHealthy

Outcome Measures

Primary Outcomes (2)

  • Area under the serum insulin degludec concentration-of s.c. administration

    From 0 to infinity after single dose

  • Area under the serum insulin degludec concentration-of i.v. administration

    From 0 to infinity after single dose

Secondary Outcomes (2)

  • Terminal half-life for insulin degludec

    From 0 to 30 hours after single dose

  • Volume of distribution of insulin degludec, estimated during the terminal phase

    From 0 to 30 hours after single dose

Study Arms (2)

s.c.

EXPERIMENTAL
Drug: insulin degludec

i.v.

EXPERIMENTAL
Drug: insulin degludec

Interventions

insulin degludecDRUG

A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).

s.c.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
  • Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

You may not qualify if:

  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Neuss, 41460, Germany

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 20, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 19, 2015

Record last verified: 2015-02

Locations

DE(1)