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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00964418
First received: August 24, 2009
Last updated: November 20, 2013
Last verified: November 2013

August 24, 2009
November 20, 2013
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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
Korsatko S, Deller S, Mader JK, Glettler K, Koehler G, Treiber G, Urschitz M, Wolf M, Hastrup H, Søndergaard F, Haahr H, Pieber TR. Ultra-long pharmacokinetic properties of insulin degludec are comparable in elderly subjects and younger adults with type 1 diabetes mellitus. Drugs Aging. 2014 Jan;31(1):47-53. doi: 10.1007/s40266-013-0138-0.

*   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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00964418
NN1250-1994, 2008-008601-21
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Hanne Hastrup-Nielsen, MSc PhD Novo Nordisk A/S
Novo Nordisk A/S
November 2013

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