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Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01173926
First received: July 30, 2010
Last updated: June 28, 2012
Last verified: May 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to compare the blood glucose-lowering effect of NN5401 with NN1250 and insulin aspart in subjects with type 1 diabetes mellitus.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: NN1250
Drug: NN5401
Drug: insulin aspart
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Comparing the Pharmacokinetic and Pharmacodynamic Properties Between NN5401 and NN1250 and Between NN5401 and Insulin Aspart in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the glucose infusion rate curve [ Time Frame: from 0 to 6 hours after single-dose (only for NN1250 and NN5401) ] [ Designated as safety issue: No ]
  • Area under the glucose infusion rate curve [ Time Frame: from 6 to 24 hours after single-dose (only for NN5401 and insulin aspart) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the serum insulin NN1250 concentration-time curve [ Time Frame: from 0 to 120 hours after single-dose (only for NN5401 and NN1250) ] [ Designated as safety issue: No ]
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0 to 12 hours after single-dose (only for NN5401 and insulin aspart) ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
Experimental: B Drug: NN5401
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
Active Comparator: C Drug: insulin aspart
Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered 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 for at least 12 months
  • Body mass index (BMI) between 18.0-28.0 kg/m2 (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 trial entry
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173926

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Kirstine Stender-Petersen Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01173926     History of Changes
Other Study ID Numbers: NN5401-3857, U1111-1114-9348, 2010-019641-26
Study First Received: July 30, 2010
Last Updated: June 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)

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 June 13, 2013