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Basal Insulins - Pharmacodynamics

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ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: Insulin detemir Drug: Insulin glargine Drug: Insulatard Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Insulin detemir
Drug: Insulin detemir
0.4 U/kg bw insulin detemir injected s.c. in the thigh.
Other Name: Levemir

Active Comparator: 2
Insulin glargine
Drug: Insulin glargine
0.4 U/kg bw insulin glargine injected s.c. in the thigh
Other Name: Lantus

Active Comparator: 3
NPH insulin
Drug: Insulatard
0.4 U/kg bw NPH insulin injected s.c. in the thigh

Primary Outcome Measures :
  1. Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. [ Time Frame: 24 hours ]

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566124

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Medical department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, DK, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Danish Diabetes Association
The Institute of Experimental Clinical Research, University of Aarhus
Novo Nordisk A/S
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Principal Investigator: Ole E. Schmitz, DMSc University of Aarhus
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Responsible Party: Ole E. Schmitz, DMSc., University of Aarhus
ClinicalTrials.gov Identifier: NCT00566124    
Other Study ID Numbers: Opus 1
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: December 3, 2007
Last Verified: November 2007
Keywords provided by University of Aarhus:
Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
Additional relevant MeSH terms:
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Insulin, Globin Zinc
Insulin Glargine
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs