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

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.
 
ClinicalTrials.gov Identifier: NCT01114542
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE April 29, 2010
First Posted Date  ICMJE May 3, 2010
Last Update Posted Date October 9, 2017
Actual Study Start Date  ICMJE May 3, 2010
Actual Primary Completion Date August 10, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes
Official Title  ICMJE A Trial Evaluating the Pharmacodynamic Response of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2010)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 10, 2010
Actual Primary Completion Date August 10, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01114542
Other Study ID Numbers  ICMJE NN1250-1993
2009-015897-36 ( EudraCT Number )
U1111-1113-6772 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date October 2017

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