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A Trial Investigating NN1218 in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01121289
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : December 10, 2013
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 absorption and effect in the body of NN1218 in subjects with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: NN1218 Drug: insulin aspart Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes
Study Start Date : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: NN1218, formulation A Drug: NN1218
0.2 U/kg body weight injected subcutaneously (under the skin)
Experimental: NN1218, formulation B Drug: NN1218
0.2 U/kg body weight injected subcutaneously (under the skin)
Experimental: NN1218, formulation B (high) Drug: NN1218
0.4 U/kg body weight injected subcutaneously (under the skin)
Experimental: NN1218, formulation C Drug: NN1218
0.2 U/kg body weight injected subcutaneously (under the skin)
Experimental: NN1218, formulation D Drug: NN1218
0.2 U/kg body weight injected subcutaneously (under the skin)
Active Comparator: insulin aspart Drug: insulin aspart
0.2 U/kg body weight injected subcutaneously (under the skin)



Primary Outcome Measures :
  1. Area under the serum NN1218 concentration-time curve [ Time Frame: From 0-1 hours ]

Secondary Outcome Measures :
  1. Area under the serum NN1218 concentration-time curve [ Time Frame: From 0-10 hours ]


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 more than 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/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 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): NCT01121289


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: NCT01121289     History of Changes
Other Study ID Numbers: NN1218-3808
U1111-1113-6955 ( Other Identifier: WHO )
2009-017121-19 ( EudraCT Number )
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs