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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
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
  Purpose

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 Intervention Phase
Diabetes
 Drug: Insulin detemir
Drug: Insulin glargine
Drug: Insulatard
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2005
Study Completion Date: May 2005
Arms Assigned Interventions
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
Other Name: Insulatard

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).

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00566124

Locations
Denmark
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
Investigators
Principal Investigator: Ole E. Schmitz, DMSc University of Aarhus
  More Information

No publications provided

Responsible Party: Ole E. Schmitz, DMSc., University of Aarhus
ClinicalTrials.gov Identifier: NCT00566124     History of Changes
Other Study ID Numbers: Opus 1, 2004-41-4474, 20040188, 2612-2731
Study First Received: November 30, 2007
Last Updated: November 30, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans

Additional relevant MeSH terms:
Glargine
Insulin
Insulin, NPH
Insulin, Long-Acting
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013