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A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00964418
First Posted: August 25, 2009
Last Update Posted: January 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
August 24, 2009
August 25, 2009
January 20, 2017
August 2009
November 2009   (Final data collection date for primary outcome measure)
Area under the glucose infusion rate curve during one dosing interval at steady state (for NN1250) [ Time Frame: 0-24 hours (derived on treatment day 6) ]
Same as current
Complete list of historical versions of study NCT00964418 on ClinicalTrials.gov Archive Site
Area under the NN1250 concentration-time curve during one dosing interval at steady state [ Time Frame: 0-24 hours (derived on treatment day 6) ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Effect of NN1250 in Young and Elderly Subjects With Type 1 Diabetes
A Trial Investigating the Pharmacodynamic and Pharmacokinetic Properties of NN1250 in Young and Geriatric Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of this clinical trial is to investigate the blood glucose lowering effect of NN1250 (insulin degludec) in young and elderly subjects with type 1 diabetes.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin degludec
    0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days
  • Drug: insulin glargine
    0.4 U/kg body weight injected s.c. (subcutaneously) once daily for 6 days
  • Experimental: IDeg
    Intervention: Drug: insulin degludec
  • Active Comparator: IGlar
    Intervention: Drug: insulin glargine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
November 2009
November 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 18-35 years (both inclusive) (young group) or at least 65 years (geriatric group)
  • 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT00964418
NN1250-1994
2008-008601-21 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP