NCT00566124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2007

Completed
Last Updated

December 3, 2007

Status Verified

November 1, 2007

First QC Date

November 30, 2007

Last Update Submit

November 30, 2007

Conditions

Diabetes

Keywords

Levemir, Lantus, Insulatard, Pharmacodynamics, Healthy humans

Outcome Measures

Primary Outcomes (1)

  • Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.

    24 hours

Study Arms (3)

1

ACTIVE COMPARATOR

Insulin detemir

Drug: Insulin detemir

2

ACTIVE COMPARATOR

Insulin glargine

Drug: Insulin glargine

3

ACTIVE COMPARATOR

NPH insulin

Drug: Insulatard

Interventions

Insulin detemirDRUG

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

Also known as: Levemir
1
Insulin glargineDRUG

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

Also known as: Lantus
2
InsulatardDRUG

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

3

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • BMI 20 - 50 kg/m2
  • Blood pressure \< 140/90 mmHg
  • signed informed consent
  • Caucasien

You may not qualify if:

  • Diabetes or other disease
  • Alcohol or drug abuse
  • Smoking
  • Use of prescription drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Aarhus, DK, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin DetemirInsulin GlargineIsophane Insulin, Human

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, IsophaneInsulin, Regular, HumanInsulinProinsulin

Study Officials

  • Ole E. Schmitz, DMSc

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 3, 2007

Study Start

January 1, 2005

Study Completion

May 1, 2005

Last Updated

December 3, 2007

Record last verified: 2007-11

Locations

DK(1)