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A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01174303
First received: August 2, 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 investigate the exposure of NN5401 in young adults and elderly subjects with type 1 diabetes mellitus.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: NN5401
Drug: biphasic insulin aspart 30
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Properties of NN5401 in Young Adults and Geriatric 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 (only for NN5401) [ Time Frame: from 0 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the glucose infusion rate curve (only for biphasic insulin aspart 30) [ Time Frame: from 0 to 24 hours after single-dose administration ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: August 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: NN5401
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of NN5401 and biphasic insulin aspart 30.
Drug: biphasic insulin aspart 30
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of NN5401 and biphasic insulin aspart 30.
Experimental: B Drug: NN5401
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of NN5401 and biphasic insulin aspart 30.
Drug: biphasic insulin aspart 30
Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of NN5401 and biphasic insulin aspart 30.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: Young adults between 18-35 years and geriatric subjects at least 65 years old
  • Type 1 diabetes mellitus for at least 12 months
  • Body mass index (BMI): 18.0-28.0 kg/m2 (both inclusive)

Exclusion Criteria:

  • 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
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
  • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174303

Locations
Austria
Graz, Austria, 8036
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Charlotte Granhall 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: NCT01174303     History of Changes
Other Study ID Numbers: NN5401-1981, U1111-1114-9373, 2009-017280-42
Study First Received: August 2, 2010
Last Updated: June 28, 2012
Health Authority: Austria: Federal Ministry for Health and Women

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 May 21, 2013