NCT00654056

Brief Summary

The purpose of the study is to investigate some of the mechanisms behind severe insulin resistance and to determine the dose response to insulin in patients with type 2 diabetes mellitus.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2008

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

March 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

March 25, 2008

Last Update Submit

March 8, 2013

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetesSevere insulin resistance

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    8 hours

Secondary Outcomes (1)

  • Changes in insulin signaling proteins?

    1 month

Study Arms (4)

L1

EXPERIMENTAL

Actrapid infusion, 0.5 mU/kg/min.

Drug: Actrapid (human insulin)

L2

EXPERIMENTAL

Actrapid infusion 1.5 mU/kg/min

Drug: Actrapid (human insulin)

H1

EXPERIMENTAL

Actrapid infusion 3.0 mU/kg/min

Drug: Actrapid (human insulin)

H2

EXPERIMENTAL

Actrapid infusion 5.0 mU/kg/min

Drug: Actrapid (human insulin)

Interventions

Actrapid (human insulin)DRUG

On day one: 0,5 IU/kg/min for 3 hours, 1,5 IU/kg/min for 3 hours, on day two: 3,0 IU/kg/min for 3 hours, 5,0 IU/kg/min for 3 hours

H1H2L1L2

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25-75 years old
  • BMI between 25 and 42

You may not qualify if:

  • Severe diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Niels Moeller, Professor

    Department M (Endocrinology and diabetes), Aarhus University Hospital, Nørrebrogade 44, 8000 Århus C, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2008

First Posted

April 7, 2008

Study Start

March 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 11, 2013

Record last verified: 2013-03