Basal Insulins - Pharmacodynamics

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Diabetes

Treatments: Drug: Insulatard; Drug: Insulin glargine; Drug: Insulin detemir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00566124

2612-2731

20040188

Opus 1

2004-41-4474

Details and patient eligibility

About

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

Full 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).

Enrollment: 10 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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10 participants in 3 patient groups

1

Active Comparator group

Description:

Insulin detemir

Treatment:

Drug: Insulin detemir

2

Active Comparator group

Description:

Insulin glargine

Treatment:

Drug: Insulin glargine

3

Active Comparator group

Description:

NPH insulin

Treatment:

Drug: Insulatard