NCT00992537

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to compare the blood glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250 (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where the trial participant will receive one single dose of each trial product in varying order.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Oct 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

3 months

First QC Date

October 8, 2009

Last Update Submit

November 26, 2013

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

  • Area under the glucose infusion rate curve

    From 0 to 6 hours after single-dose administration

  • Area under the glucose infusion rate curve

    From 4 to 24 hours after single-dose administration

Secondary Outcomes (4)

  • Area under the insulin degludec concentration-time curve

    From 0 to 120 hours after single-dose administration

  • Maximum observed insulin degludec concentration

    From 0 to 120 hours after single-dose administration

  • Area under the insulin aspart concentration-time curve

    From 0 to 12 hours after single-dose administration

  • Maximum observed insulin aspart concentration

    0-12 hours after single-dose administration

Study Arms (3)

IDeg

EXPERIMENTAL
Drug: insulin degludec

IDegAsp

EXPERIMENTAL
Drug: insulin degludec/insulin aspart

IAsp

ACTIVE COMPARATOR
Drug: insulin aspart

Interventions

insulin degludecDRUG

Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

IDeg
insulin degludec/insulin aspartDRUG

Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

IDegAsp
insulin aspartDRUG

Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).

IAsp

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index 18.0-28.0 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 MellitusDiabetes Mellitus, Type 1

Interventions

insulin degludecinsulin degludec, insulin aspart drug combinationInsulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

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

October 8, 2009

First Posted

October 9, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

DE(1)