Basal Insulins - Pharmacodynamics

• ClinicalTrials.gov Identifier: NCT00566124
• Recruitment Status: Completed
• First Posted: December 3, 2007
• Last Update Posted: December 3, 2007
• Sponsor: University of Aarhus
• Collaborators: The Danish Diabetes Association; The Institute of Experimental Clinical Research, University of Aarhus; Novo Nordisk A/S
• Information provided by: University of Aarhus

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Diabetes	Drug: Insulin detemir; Drug: Insulin glargine; Drug: Insulatard	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: January 2005
• Actual Study Completion Date: May 2005

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate. [ Time Frame: 24 hours ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 50 Years (Adult)
• Sexes 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

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 A/S

Investigators

• Principal Investigator: Ole E. Schmitz, DMSc; University of Aarhus

More Information

• Responsible Party: Ole E. Schmitz, DMSc., University of Aarhus
• ClinicalTrials.gov Identifier: NCT00566124
• Other Study ID Numbers: Opus 1; 2004-41-4474; 20040188; 2612-2731
• First Posted: December 3, 2007
• Last Update Posted: December 3, 2007
• Last Verified: November 2007

Keywords provided by University of Aarhus:

Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans

Additional relevant MeSH terms:

Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef; Hypoglycemic Agents; Physiological Effects of Drugs