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Completed

NCT Number: NCT00566124

Basal Insulins - Pharmacodynamics

To purpose of this study is to compare the pharmacodynamic properties of insulin detemir, insulin glargine and NPH insulin after a single subcutaneous injection.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital

Aarhus, DK, 8000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

0.4 U/kg bw insulin detemir injected s.c. in the thigh.

Other names: Levemir

insulin glargine

Drug

0.4 U/kg bw insulin glargine injected s.c. in the thigh

Other names: Lantus

Insulatard

Drug

0.4 U/kg bw NPH insulin injected s.c. in the thigh

Primary outcomes

  1. Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Novo Nordisk A/S
  • The Danish Diabetes Association
  • The Institute of Experimental Clinical Research, University of Aarhus

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2005
First posted
Dec 3, 2007
Registry last updated
Dec 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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