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

November 30, 2007
December 3, 2007
December 3, 2007
January 2005
Not Provided
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. [ Time Frame: 24 hours ]
Same as current
No Changes Posted
Not Provided
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Basal Insulins - Pharmacodynamics
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
To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.
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).
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2005
Not Provided

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
Sexes Eligible for Study: Male
20 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Opus 1
Not Provided
Not Provided
Ole E. Schmitz, DMSc., University of Aarhus
University of Aarhus
  • The Danish Diabetes Association
  • The Institute of Experimental Clinical Research, University of Aarhus
  • Novo Nordisk A/S
Principal Investigator: Ole E. Schmitz, DMSc University of Aarhus
University of Aarhus
November 2007

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