A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01924637
First received: August 14, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

This trial is conducted in Europe. The aim of the trial is to investigate 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) in subjects with type 1 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin aspart (FIAsp)
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Mean change in plasma glucose concentration [ Time Frame: From 0-2 hours after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 1 hour ] [ Designated as safety issue: No ]
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: August 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FIASP
Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal.
Drug: insulin aspart (FIAsp)

A single dose will be administered subcutaneously (under the skin) in the abdomen.

Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.

Active Comparator: NovoRapid®
Each treatment period consists of 1 dosing visit during which the subject will receive a single dose of either insulin aspart or FIAsp at a predefined fixed dose level (in random sequence) in connection to intake of a standardised meal.
Drug: insulin aspart

A single dose will be administered subcutaneously (under the skin)) in the abdomen.

Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days.


  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 more than 5 cigarettes or the equivalent per day)
  • Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period inpatient period
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924637

Locations
Austria
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01924637     History of Changes
Other Study ID Numbers: NN1218-3889, 2011-000941-19, U1111-1119-5708
Study First Received: August 14, 2013
Last Updated: December 10, 2013
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014