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A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01121276
First received: May 10, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Drug: NN1218
Drug: insulin aspart
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the blood glucose concentration-time curve [ Time Frame: from 0-2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the blood glucose concentration-time curve [ Time Frame: from 0-6 hours ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes mellitus for more than 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
  • Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)

Exclusion Criteria:

  • Surgery or trauma with significant blood loss (more than 500 mL) within the last 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121276

Locations
United States, California
Novo Nordisk Clinical Trial Call Center
Chula Vista, California, United States, 91911
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lene Jensen Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01121276     History of Changes
Other Study ID Numbers: NN1218-3824, U1111-1113-6897, 2009-017627-25
Study First Received: May 10, 2010
Last Updated: October 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin Aspart
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014