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A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01296438
First Posted: February 15, 2011
Last Update Posted: February 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin aspart.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Faster-acting insulin aspart Drug: insulin aspart Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Trial Investigating the Pharmacokinetic Properties of NN1218 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 under the serum insulin aspart concentration-time curve [ Time Frame: from 0-1 hour after trial drug administration ]

Secondary Outcome Measures:
  • Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0-12 hours after trial drug administration ]

Enrollment: 40
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment sequence 1 Drug: Faster-acting insulin aspart
Single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin)
Other Name: NN1218
Active Comparator: Treatment sequence 2 Drug: insulin aspart
Single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin)

  Eligibility

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 for at least 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months.
  • Body Mass Index (BMI) between 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 trial start
  • 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 gum or transdermal nicotine patches during the inpatient period
  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): NCT01296438


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:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01296438     History of Changes
Other Study ID Numbers: NN1218-3872
2010-022222-33 ( EudraCT Number )
U1111-1118-6955 ( Other Identifier: WHO )
First Submitted: February 14, 2011
First Posted: February 15, 2011
Last Update Posted: February 23, 2015
Last Verified: February 2015

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 degludec, insulin aspart drug combination
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs