NCT01173926

Brief Summary

This trial is conducted in Europe. The aim of this 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 mellitus.

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 Jul 2010

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

July 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

4 months

First QC Date

July 30, 2010

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 (only for IDeg and IDegAsp)

  • Area under the glucose infusion rate curve

    From 6 to 24 hours after single-dose (only for IDegAsp and IAsp)

Secondary Outcomes (2)

  • Area under the serum insulin degludec concentration-time curve

    From 0 to 120 hours after single-dose (only for IDeg and IDegAsp)

  • Area under the serum insulin aspart concentration-time curve

    From 0 to 12 hours after single-dose (only for IDegAsp and IAsp)

Study Arms (3)

IAsp

EXPERIMENTAL
Drug: insulin aspart

IDeg

EXPERIMENTAL
Drug: insulin degludec

IDegAsp

EXPERIMENTAL
Drug: insulin degludec/insulin aspart

Interventions

insulin degludecDRUG

Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).

IDeg
insulin degludec/insulin aspartDRUG

Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).

IDegAsp
insulin aspartDRUG

Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered 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

July 30, 2010

First Posted

August 2, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations

DE(1)