A Trial Investigating the Pharmacokinetic Properties of Formulations of NN1218 in Subjects With Type 1 Diabetes

February 20, 2015 updated by: Novo Nordisk A/S
This trial is conducted in Europe. The purpose of this trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of different formulations of NN1218.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitus for more than 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months
  • Body mass index (BMI) between 18.0-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Subjects who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
  • 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

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NN1218
Drug: Faster-acting insulin aspart
Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
Other Names:
  • NN1218
Active Comparator: insulin aspart
Drug: insulin aspart
At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 1 hour
From 0 to 1 hour

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 observed serum insulin aspart concentration
Time Frame: From 0 to 12 hours
From 0 to 12 hours
Time to maximum observed serum insulin aspart concentration
Time Frame: From 0 to 12 hours
From 0 to 12 hours

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.

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

November 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2015

Last Update Submitted That Met QC Criteria

February 20, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1218-3977
  • 2011-004081-15 (EudraCT Number)
  • U1111-1123-6692 (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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