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

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ClinicalTrials.gov Identifier: NCT01296438
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: Faster-acting insulin aspart Drug: insulin aspart Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : February 2011
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Area under the serum insulin aspart concentration-time curve [ Time Frame: from 0-1 hour after trial drug administration ]

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


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

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

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 Posted: February 15, 2011    Key Record Dates
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