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A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01618188
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamic properties (the effect of the investigated drug on the body) of NN1218 in subjects with type 1 diabetes.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 Diabetes
Actual Study Start Date : June 11, 2012
Actual Primary Completion Date : September 7, 2012
Actual Study Completion Date : September 7, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Formulation A Drug: Faster-acting insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Other Name: NN1218
Experimental: Formulation B Drug: Faster-acting insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Other Name: NN1218
Active Comparator: Insulin Aspart Drug: insulin aspart
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.


Outcome Measures
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Primary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: From 0 to 2 hours ]

Secondary Outcome Measures :
  1. Area under the glucose infusion rate curve [ Time Frame: From 0 to 12 hours ]
  2. Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ]
  3. Time to maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 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 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 substitute products during the inpatient period
Contacts and Locations
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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): NCT01618188


Locations
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Germany
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

Other Publications:
Haahr H, Hövelmann U, Brøndsted L, Adrian CL, Nosek L, Heise T. Higher Early Insulin Exposure and Greater Early Glucose-lowering Effect with Faster-acting Insulin Aspart in Patients with Type 1 Diabetes Mellitus (T1DM). Diabetes 2014; 63 ((Suppl 1)): A233 (abstract 910-P)
Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01618188    
Other Study ID Numbers: NN1218-3978
U1111-1126-0900 ( Other Identifier: WHO )
2011-005796-16 ( EudraCT Number )
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs