NCT00993096

Brief Summary

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes. The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 diabetes

Timeline
Completed

Started Sep 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

September 1, 2009

Completed
1 month 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
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

October 8, 2009

Last Update Submit

February 9, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area (AUC) under the glucose infusion rate curve

    From 0 to 24 hours after single-dose administration

Secondary Outcomes (1)

  • Area (AUC) under the insulin aspart concentration time curve

    From 0 to 24 hours after single-dose administration

Study Arms (6)

IDegAsp low

EXPERIMENTAL
Drug: insulin degludec/insulin aspart

IDegAsp middle

EXPERIMENTAL
Drug: insulin degludec/insulin aspart

IDegAsp high

EXPERIMENTAL
Drug: insulin degludec/insulin aspart

BIAsp 30 low

EXPERIMENTAL
Drug: biphasic insulin aspart 30

BIAsp 30 middle

EXPERIMENTAL
Drug: biphasic insulin aspart 30

BIAsp 30 high

EXPERIMENTAL
Drug: biphasic insulin aspart 30

Interventions

insulin degludec/insulin aspartDRUG

Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)

IDegAsp low
biphasic insulin aspart 30DRUG

Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)

BIAsp 30 low

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)
  • Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
  • 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)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

  • Heise T, Nosek L, Klein O, Coester H, Svendsen AL, Haahr H. Insulin degludec/insulin aspart produces a dose-proportional glucose-lowering effect in subjects with type 1 diabetes mellitus. Diabetes Obes Metab. 2015 Jul;17(7):659-64. doi: 10.1111/dom.12463. Epub 2015 May 1.

    PMID: 25772444RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

insulin degludec, insulin aspart drug combinationinsulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune 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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
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

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

DE(1)