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Basal Insulins - Pharmacodynamics

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 3, 2007
Last Update Posted: December 3, 2007
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.
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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
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