A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01030926
First received: December 11, 2009
Last updated: November 20, 2013
Last verified: November 2013

December 11, 2009
November 20, 2013
December 2009
May 2010   (final data collection date for primary outcome measure)
Area under the NN1250 concentration-time curve after single dose [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01030926 on ClinicalTrials.gov Archive Site
  • Maximum observed NN1250 concentration after single dose [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]
  • Time to maximum observed NN1250 concentration after single dose [ Time Frame: 0-72 hours after dosing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes

This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics 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 subcutaneously (under the skin), single dose
  • Drug: insulin glargine
    0.4 U/kg body weight injected subcutaneously (under the skin), single dose
  • Experimental: A1, first period
    Intervention: Drug: insulin degludec
  • Active Comparator: A2, second period
    Intervention: Drug: insulin glargine
  • Active Comparator: B1, first period
    Intervention: Drug: insulin glargine
  • Experimental: B2, second period
    Intervention: Drug: insulin degludec
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 6-65 years (both inclusive)
  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Body mass index for children: 15.0-20.0 kg/m^2 (both inclusive), for adolescents: 18.0-28.0 kg/m^2 (both inclusive) and for adults maximum 30.0 kg/m^2

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
  • Not able or willing to refrain from smoking during the inpatient period
  • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Both
6 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01030926
NN1250-1995, 2008-008306-43, U1111-1112-4715
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Tove K. Stryhn, MSc. Pharm 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