ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02033239
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting insulin aspart (FIAsp) in subjects with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Faster-acting insulin aspart Drug: insulin aspart Phase 1

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Response of FIAsp in Subjects With Type 1 Diabetes
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: FIAsp
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
 Drug: Faster-acting insulin aspart
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).
Active Comparator: NovoRapid®
Each subject will be randomised to a treatment sequence consisting of 8 treatment periods
 Drug: insulin aspart
Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: From 0 to 12 hours ]

Secondary Outcome Measures :
  1. Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours ]
  2. Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ]
  3. Maximum observed serum insulin aspart concentration [ Time Frame: Within 0 to 12 hours after dosing ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 18.5-28.0 kg/m^2 (both inclusive)

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
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033239


Locations
Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications:
Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02033239     History of Changes
Other Study ID Numbers: NN1218-3887
2011-001580-41 ( EudraCT Number )
U1111-1120-3772 ( Other Identifier: WHO )
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs