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A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01590836
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic response (the effect of the investigated drug on the body) of insulin degludec/insulin aspart (IDegAsp) at steady state in subjects with type 1 diabetes.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Properties of NN5401 in Subjects With Type 1 Diabetes
Study Start Date : April 2012
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: IDeg-->IDegAsp Drug: insulin degludec
Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).
Drug: insulin degludec/insulin aspart
Single dose administered subcutaneously (s.c., under the skin).


Outcome Measures

Primary Outcome Measures :
  1. Area under the glucose infusion rate curve during one dosing interval [ Time Frame: At steady state (0-24 hours) ]

Secondary Outcome Measures :
  1. Maximum glucose infusion rate (GIRmax) [ Time Frame: At steady state (within 0-24 hours after last dosing) ]
  2. Area under the serum insulin degludec concentration-time curve during one dosing interval [ Time Frame: At steady state (within 0-24 hours after last dosing) ]
  3. Maximum observed serum insulin degludec concentration [ Time Frame: At steady state (within 0-24 hours after last dosing) ]
  4. Area under the serum insulin aspart concentration-time curve [ Time Frame: From 0 to 12 hours ]
  5. Maximum observed serum insulin aspart concentration [ Time Frame: Within 0-12 hours after dosing of IDegAsp ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
  • Body mass index (BMI) 18.0-28.0 kg/m^2 (both inclusive)
  • Glycosylated haemoglobin (HbA1c) maximum 9.5 %
  • Fasting C-peptide maximum 0.3 nmol/L

Exclusion Criteria:

  • 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, use of nicotine gum or transdermal nicotine patches during the inpatient period
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to screening
Contacts and Locations

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): NCT01590836


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

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01590836     History of Changes
Other Study ID Numbers: NN5401-1979
2011-003797-90 ( EudraCT Number )
U1111-1123-3837 ( Other Identifier: WHO )
First Posted: May 3, 2012    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 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
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs