NCT01590836

Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

April 30, 2012

Last Update Submit

February 9, 2017

Conditions

DiabetesDiabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

  • Area under the glucose infusion rate curve during one dosing interval

    At steady state (0-24 hours)

Secondary Outcomes (5)

  • Maximum glucose infusion rate (GIRmax)

    At steady state (within 0-24 hours after last dosing)

  • Area under the serum insulin degludec concentration-time curve during one dosing interval

    At steady state (within 0-24 hours after last dosing)

  • Maximum observed serum insulin degludec concentration

    At steady state (within 0-24 hours after last dosing)

  • Area under the serum insulin aspart concentration-time curve

    From 0 to 12 hours

  • Maximum observed serum insulin aspart concentration

    Within 0-12 hours after dosing of IDegAsp

Study Arms (1)

IDeg-->IDegAsp

EXPERIMENTAL
Drug: insulin degludecDrug: insulin degludec/insulin aspart

Interventions

insulin degludecDRUG

Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).

IDeg-->IDegAsp
insulin degludec/insulin aspartDRUG

Single dose administered subcutaneously (s.c., under the skin).

IDeg-->IDegAsp

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
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
  • Body mass index (BMI) 18.0-28.0 kg/m\^2 (both inclusive)
  • Glycosylated haemoglobin (HbA1c) maximum 9.5 %
  • Fasting C-peptide maximum 0.3 nmol/L

You may not qualify if:

  • 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, use of nicotine gum or transdermal nicotine patches during the inpatient period
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening

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, Roepstorff C, Chenji S, Klein O, Haahr H. Distinct Prandial and Basal Glucose-Lowering Effects of Insulin Degludec/Insulin Aspart (IDegAsp) at Steady State in Subjects with Type 1 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):255-65. doi: 10.1007/s13300-014-0070-2. Epub 2014 Jun 3.

    PMID: 24888255RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

insulin degludecinsulin degludec, insulin aspart drug combination

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 3, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

DE(1)