A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

February 9, 2017 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany, 41460
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IDeg-->IDegAsp
Drug: insulin degludec
Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).
Drug: insulin degludec/insulin aspart
Single dose administered subcutaneously (s.c., under the skin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the glucose infusion rate curve during one dosing interval
Time Frame: At steady state (0-24 hours)
At steady state (0-24 hours)

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 12 hours
From 0 to 12 hours
Maximum glucose infusion rate (GIRmax)
Time Frame: At steady state (within 0-24 hours after last dosing)
At steady state (within 0-24 hours after last dosing)
Area under the serum insulin degludec concentration-time curve during one dosing interval
Time Frame: At steady state (within 0-24 hours after last dosing)
At steady state (within 0-24 hours after last dosing)
Maximum observed serum insulin degludec concentration
Time Frame: At steady state (within 0-24 hours after last dosing)
At steady state (within 0-24 hours after last dosing)
Maximum observed serum insulin aspart concentration
Time Frame: Within 0-12 hours after dosing of IDegAsp
Within 0-12 hours after dosing of IDegAsp

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN5401-1979
  • 2011-003797-90 (EudraCT Number)
  • U1111-1123-3837 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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