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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Drug: Insulin detemir; Drug: Insulin glargine; Drug: 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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • DK
    • Aarhus, DK, Denmark, 8000
      • Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: Levemir
Active Comparator: 2; Insulin glargine	Drug: Insulin glargine; 0.4 U/kg bw insulin glargine injected s.c. in the thigh; Other Names: Lantus
Active Comparator: 3; NPH insulin	Drug: Insulatard; 0.4 U/kg bw NPH insulin injected s.c. in the thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.	24 hours

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Novo Nordisk A/S; The Danish Diabetes Association; The Institute of Experimental Clinical Research, University of Aarhus
• Investigators: Principal Investigator: Ole E. Schmitz, DMSc, University of Aarhus

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: November 30, 2007
• First Submitted That Met QC Criteria: November 30, 2007
• First Posted (Estimate): December 3, 2007

Study Record Updates

• Last Update Posted (Estimate): December 3, 2007
• Last Update Submitted That Met QC Criteria: November 30, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
• Other Study ID Numbers: Opus 1; 2004-41-4474; 20040188; 2612-2731