A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes

November 7, 2016 updated by: Novo Nordisk A/S
This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) and insulin aspart (NovoRapid®) given as a bolus on top of a basal continuous subcutaneous insulin infusion (CSII).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

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 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
  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index (BMI) 18.5-28.0 kg/m^2 (both inclusive)
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months

Exclusion Criteria:

  • 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 at least one cigarette, cigar or pipe daily)
  • Not able or willing to refrain from smoking and use of nicotine substitute products 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FIAsp followed by NovoRapid®
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
Drug: Faster-acting insulin aspart

Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.

The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.
EXPERIMENTAL: NovoRapid® followed by FIAsp
Each subject will be randomly allocated to a treatment sequence consisting of 2 dosing visits separated by a wash-out period of 3-12 days
Drug: insulin aspart

Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.

The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 30 minutes
From 0 to 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
CSII bolus related baseline corrected area under the serum insulin aspart concentration-time curve
Time Frame: From 0 to 1 hour
From 0 to 1 hour
CSII bolus related baseline corrected area under the glucose infusion rate curve
Time Frame: From 0 to 1 hour
From 0 to 1 hour

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

November 1, 2013

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1218-3890
  • 2011-000913-37 (EUDRACT_NUMBER)
  • U1111-1119-5358 (OTHER: 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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