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Basal Insulins - Pharmacodynamics

NCT ID: NCT00566124

Last Updated: 2007-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-05-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Diabetes

Keywords

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Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Insulin detemir

Group Type ACTIVE_COMPARATOR

Insulin detemir

Intervention Type DRUG

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

2

Insulin glargine

Group Type ACTIVE_COMPARATOR

Insulin glargine

Intervention Type DRUG

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

3

NPH insulin

Group Type ACTIVE_COMPARATOR

Insulatard

Intervention Type DRUG

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

Interventions

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Insulin detemir

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

Intervention Type DRUG

Insulin glargine

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

Intervention Type DRUG

Insulatard

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

Intervention Type DRUG

Other Intervention Names

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Levemir Lantus

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Diabetes Association

OTHER

Sponsor Role collaborator

The Institute of Experimental Clinical Research, University of Aarhus

UNKNOWN

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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University of Aarhus

Principal Investigators

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Ole E. Schmitz, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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

Aarhus, DK, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2004-41-4474

Identifier Type: -

Identifier Source: secondary_id

20040188

Identifier Type: -

Identifier Source: secondary_id

2612-2731

Identifier Type: -

Identifier Source: secondary_id

Opus 1

Identifier Type: -

Identifier Source: org_study_id