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Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01076634
First received: February 24, 2010
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 formulations in subjects with type 1 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: NN1250
 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 NN1250 in Subjects With Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • AUC area under the glucose infusion rate curve during one dosing interval at steady-date" after [ Time Frame: after 8 days of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC area under the serum NN1250 concentration-time curve [ Time Frame: during one dosing interval at steady state ] [ Designated as safety issue: No ]
  • AUC area under the serum NN1250 concentration-time curve [ Time Frame: from 0 to 24 hours after single dose ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
NN1250, 0.4 U/kg body weight, formulation 1. Injected subcutaneously (under the skin) once daily for 8 days.
Experimental: B Drug: NN1250
NN1250, 0.4 U/kg body weight, formulation 2. Injected subcutaneously (under the skin) once daily for 8 days.

  Eligibility

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

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months
  • Body Mass Index (BMI) 18-28 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 study start
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076634

Locations
Austria
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Birgitte Esmarck Meibom, phD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01076634     History of Changes
Other Study ID Numbers: NN1250-3678, U1111-1112-7714
Study First Received: February 24, 2010
Last Updated: June 29, 2012
Health Authority: Austria: AGES PharmMed

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013