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Basal Insulins - Pharmacodynamics

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. Identifier: NCT00566124
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : December 3, 2007
The Danish Diabetes Association
The Institute of Experimental Clinical Research, University of Aarhus
Novo Nordisk A/S
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE November 30, 2007
First Posted Date  ICMJE December 3, 2007
Last Update Posted Date December 3, 2007
Study Start Date  ICMJE January 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2007)
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Basal Insulins - Pharmacodynamics
Official Title  ICMJE No Evidence for Essential Differences Between the Effects of Insulin Glargine, Insulin Detemir and NPH Insulin on Glucose Metabolism After a Single Injection as Assessed by 24-h Euglycemic Clamp Studies in Healthy Humans
Brief Summary To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.
Detailed Description In this randomized, double-blind, euglycemic glucose clamp study, 10 healthy male volunteers received a subcutaneous injection of 0.4 U/kg insulin detemir, insulin glargine or NPH insulin on three separate study days in a cross-over design. After insulin administration, plasma glucose was maintained at 0.3 mmol/l below fasting level for 24 hours by manually adjusted glucose infusion. C-peptide, insulin, NEFA and counter regulatory hormones were measured throughout the clamp period. Endogenous glucose release (EGR) was assessed by the isotope dilution technique (3-3H-glucose).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes
Intervention  ICMJE
  • Drug: Insulin detemir
    0.4 U/kg bw insulin detemir injected s.c. in the thigh.
    Other Name: Levemir
  • Drug: Insulin glargine
    0.4 U/kg bw insulin glargine injected s.c. in the thigh
    Other Name: Lantus
  • Drug: Insulatard
    0.4 U/kg bw NPH insulin injected s.c. in the thigh
Study Arms  ICMJE
  • Active Comparator: 1
    Insulin detemir
    Intervention: Drug: Insulin detemir
  • Active Comparator: 2
    Insulin glargine
    Intervention: Drug: Insulin glargine
  • Active Comparator: 3
    NPH insulin
    Intervention: Drug: Insulatard
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2007)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male
  • BMI 20 - 50 kg/m2
  • Blood pressure < 140/90 mmHg
  • signed informed consent
  • Caucasien

Exclusion Criteria:

  • Diabetes or other disease
  • Alcohol or drug abuse
  • Smoking
  • Use of prescription drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00566124
Other Study ID Numbers  ICMJE Opus 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ole E. Schmitz, DMSc., University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • The Danish Diabetes Association
  • The Institute of Experimental Clinical Research, University of Aarhus
  • Novo Nordisk A/S
Investigators  ICMJE
Principal Investigator: Ole E. Schmitz, DMSc University of Aarhus
PRS Account University of Aarhus
Verification Date November 2007

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