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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01618188
First received: June 11, 2012
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
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 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the glucose infusion rate curve [ Time Frame: From 0 to 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the glucose infusion rate curve [ Time Frame: From 0 to 12 hours ] [ Designated as safety issue: No ]
  • Maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ] [ Designated as safety issue: No ]
  • Time to maximum glucose infusion rate [ Time Frame: Within 0 to 12 hours after dosing ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation A Drug: NN1218
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
Experimental: Formulation B Drug: NN1218
A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
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: NCT01618188

Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Nanna Marie Lind Novo Nordisk A/S
Study Director: Charlotte Lindorff Adrian Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01618188     History of Changes
Other Study ID Numbers: NN1218-3978, U1111-1126-0900, 2011-005796-16
Study First Received: June 11, 2012
Last Updated: September 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
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 October 20, 2014