Basal Insulins - Pharmacodynamics

This study has been completed.
Sponsor:
Collaborators:
The Danish Diabetes Association
The Institute of Experimental Clinical Research, University of Aarhus
Novo Nordisk A/S
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00566124
First received: November 30, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted

November 30, 2007
November 30, 2007
January 2005
Not Provided
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes
  • 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
    Other Name: Insulatard
  • 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.
 
Completed
10
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
Male
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00566124
Opus 1, 2004-41-4474, 20040188, 2612-2731
No
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