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Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01076634
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : January 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacodynamic Properties of NN1250 in Subjects With Type 1 Diabetes
Study Start Date : February 2010
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: IDeg 100 U/mL Drug: insulin degludec
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
Experimental: IDeg 200 U/mL Drug: insulin degludec
0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.


Outcome Measures

Primary Outcome Measures :
  1. Area under the glucose infusion rate curve during one dosing interval at steady-date" [ Time Frame: After 8 days of treatment ]

Secondary Outcome Measures :
  1. Area under the serum Insulin Degludec concentration-time curve [ Time Frame: During one dosing interval at steady state ]
  2. Area under the serum Insulin Degludec concentration-time curve [ Time Frame: From 0 to 24 hours after single dose ]

Eligibility Criteria

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 (as diagnosed clinically) for at least 12 months
  • Body mass index 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 screening
  • 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

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): NCT01076634


Locations
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01076634     History of Changes
Other Study ID Numbers: NN1250-3678
2009-014555-68 ( EudraCT Number )
U1111-1112-7714 ( Other Identifier: WHO )
First Posted: February 26, 2010    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017

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