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A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00961324
First received: August 17, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes

August 17, 2009
June 29, 2012
July 2009
October 2009   (final data collection date for primary outcome measure)
Area under the glucose infusion rate curve during one dosing interval at steady state [ Time Frame: 0-24 hours (derived on treatment days 6, 9 and 12) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00961324 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 days 6, 9 and 12) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Trial Investigating the Within-subject Variability of NN1250 in Subjects With Type 1 Diabetes
A Trial Investigating the Within-subject Variability of NN1250 With Respect to Pharmacodynamic Response at Steady State Conditions in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the variability in the blood glucose-lowering effect of NN1250 in subjects with type 1 diabetes.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: NN1250
    The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days
  • Drug: insulin glargine
    The dose level will be 0.4 units per kg body weight injected subcutaneously (under the skin) once daily for 12 days
  • Experimental: A
    Intervention: Drug: NN1250
  • Active Comparator: B
    Intervention: Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus for at least 12 months
  • Body mass index 18.0-28.0 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 trial entry
  • 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
Germany
 
NCT00961324
NN1250-1991, 2008-008308-42
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Tove K. Stryhn, MSc Pharm Novo Nordisk
Novo Nordisk
June 2012

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