Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

December 7, 2018 updated by: Novo Nordisk A/S

A Randomised Trial Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

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

  • Austria
      • Graz, Austria, 8010
        • 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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
  • Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
  • Body mass index 18.5-28.0 kg/m^2 (both inclusive)

Exclusion Criteria:

  • Smoker (defined as a subject who is smoking at least five cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or 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

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: Faster aspart
Drug: Faster-acting insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
Active Comparator: Insulin aspart
Drug: insulin aspart
Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in plasma glucose concentration
Time Frame: From 0-1 hour after trial product administration
From 0-1 hour after trial product administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of endogenous glucose production
Time Frame: From 0-6 hours after trial product administration
From 0-6 hours after trial product administration
Area under the serum insulin aspart concentration-time curve
Time Frame: From 0-6 hours after trial product administration
From 0-6 hours after trial product administration

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 (Actual)

October 6, 2015

Primary Completion (Actual)

April 25, 2016

Study Completion (Actual)

April 25, 2016

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1218-3922
  • 2014-004144-35 (EudraCT Number)
  • U1111-1162-2053 (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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