A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01114542
First received: April 29, 2010
Last updated: October 25, 2013
Last verified: October 2013

April 29, 2010
October 25, 2013
May 2010
August 2010   (final data collection date for primary outcome measure)
Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]
Area under the NN1250 glucose infusion rate curve during one dosing interval at steady state [ Time Frame: 0-42 hours after dosing on day 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01114542 on ClinicalTrials.gov Archive Site
  • Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve during one dosing interval at steady state for insulin glargine [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]
  • Area under the insulin glargine glucose infusion rate curve during one dosing interval at steady state [ Time Frame: 0-24 hours after dosing on day 8 ] [ Designated as safety issue: No ]
  • Area under the concentration-time curve during one dosing interval at steady state for NN1250 and insulin glargine [ Time Frame: 0-42 hours after dosing on day 8 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes
A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes

This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
  • Drug: insulin degludec
    Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
  • Drug: insulin glargine
    Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
  • Experimental: IDeg 0.4 U/kg
    Intervention: Drug: insulin degludec
  • Experimental: IDeg 0.6 U/kg
    Intervention: Drug: insulin degludec
  • Experimental: IDeg 0.8 U/kg
    Intervention: Drug: insulin degludec
  • Active Comparator: IGlar 0.4 U/kg
    Intervention: Drug: insulin glargine
  • Active Comparator: IGlar 0.6 U/kg
    Intervention: Drug: insulin glargine
  • Active Comparator: IGlar 0.8 U/kg
    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
66
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
  • Current total daily insulin treatment lower than 1.2 (I)U/kg/day
  • Body mass index 18.0-28.0 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
  • 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
  • Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01114542
NN1250-1993, 2009-015897-36, U1111-1113-6772
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Charlotte Granhall, MSc. PhD Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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