Investigation of the Response Relationship of NN5401 in Type 1 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00993096
First received: October 8, 2009
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the pharmacodynamic dose-response relationship of NN5401 (insulin degludec/insulin aspart) at three therapeutically relevant doses in subjects with type 1 diabetes.

The trial is designed as a four period, incomplete block cross-over trial where the trial participant will be randomised to a treatment sequence by which the subject will receive two matched dose levels of NN5401 and biphasic insulin aspart, respectively.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec/insulin aspart
Drug: biphasic insulin aspart 30
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 Pharmacodynamic Response of NN5401 in Subjects With Type 1 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area (AUC) under the glucose infusion rate curve [ Time Frame: From 0 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area (AUC) under the insulin aspart concentration time curve [ Time Frame: From 0 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IDegAsp low Drug: insulin degludec/insulin aspart
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Experimental: IDegAsp middle Drug: insulin degludec/insulin aspart
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Experimental: IDegAsp high Drug: insulin degludec/insulin aspart
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)
Experimental: BIAsp 30 low Drug: biphasic insulin aspart 30
Single dose of 0.4 U/kg body weight injected subcutaneously (under the skin)
Experimental: BIAsp 30 middle Drug: biphasic insulin aspart 30
Single dose of 0.6 U/kg body weight injected subcutaneously (under the skin)
Experimental: BIAsp 30 high Drug: biphasic insulin aspart 30
Single dose of 0.8 U/kg body weight injected subcutaneously (under the skin)

  Eligibility

Ages Eligible for Study:   18 Years to 65 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 18.0-28.0 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)
  • Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
  • Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the 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: NCT00993096

Locations
Germany
Neuss, Germany, 41460
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: NCT00993096     History of Changes
Other Study ID Numbers: NN5401-3539, 2008-008472-14, U1111-1111-9032
Study First Received: October 8, 2009
Last Updated: June 25, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014