A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

January 16, 2017 updated by: Novo Nordisk A/S

A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

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

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • 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 or type 2 diabetes mellitus for more than 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
  • Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)

Exclusion Criteria:

  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 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
Active Comparator: insulin aspart
Drug: insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
Experimental: NN1218, formulation A
Drug: Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
Other Names:
  • NN1218
Experimental: NN1218, formulation B
Drug: Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
Other Names:
  • NN1218
Experimental: NN1218, formulation C
Drug: Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
Other Names:
  • NN1218
Experimental: NN1218, formulation D
Drug: Faster-acting insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)
Other Names:
  • NN1218

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the blood glucose concentration-time curve
Time Frame: from 0-2 hours
from 0-2 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the blood glucose concentration-time curve
Time Frame: from 0-6 hours
from 0-6 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.

General Publications

  • Heise T, Haahr H, Jensen L, Ericsen L, Hompesch M. Faster-acting Insulin Aspart Improves Postprandial Glycemia vs Insulin Aspart in Patients with Type 1 Diabetes Mellitus (T1DM). Diabetes 2014; 63 ((Suppl 1)): A34 (abstract 129-OR)

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, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN1218-3824
  • U1111-1113-6897 (Other Identifier: WHO)
  • 2009-017627-25 (EudraCT Number)

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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