Basal Insulins - Pharmacodynamics

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00566124
• Other study ID #: Opus 1
• Secondary ID: 2004-41-44742004
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2007
• Last updated: November 30, 2007
• Start date: January 2005
• Est. completion date: May 2005

Study information

• Verified date: November 2007
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• Insulin detemir
0.4 U/kg bw insulin detemir injected s.c. in the thigh.
• Insulin glargine
0.4 U/kg bw insulin glargine injected s.c. in the thigh
• Insulatard
0.4 U/kg bw NPH insulin injected s.c. in the thigh

Locations

Country	Name	City	State
Denmark	Medical department M (Endocrinology and Diabetes), Aarhus University Hospital	Aarhus	DK

Sponsors (4)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.		24 hours	No