NCT00607737

Brief Summary

To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes \- The patient serves as his own control, n=100 patients with diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus

Timeline
Completed

Started Jan 2008

Typical duration for phase_4 diabetes-mellitus

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

September 3, 2012

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

January 23, 2008

Last Update Submit

August 31, 2012

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • laser doppler blood flow

    10 minutes - 7 days

Secondary Outcomes (2)

  • clinical signs

    10 min - 7 days

  • insulin detemir specific antibodies

    3 months

Study Arms (2)

1

EXPERIMENTAL

insulin detemir

Drug: insulin detemir

2

PLACEBO COMPARATOR

saline

Drug: saline

Interventions

insulin detemirDRUG

3 cutaneous injections

1
salineDRUG

3 cutaneous injections

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes mellitus
  • HbA1c\<11 %
  • BMI: 20-35 kg/m2
  • Insulin detemir naive
  • Basal insulin dose\>20E

You may not qualify if:

  • Known allergy to study drug
  • Current steroid or antiallergic treatment
  • Lipodystrophy
  • Change in insulin and antihypertensive treatment \< 30 days
  • Smokers or alcoholics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin DetemirSodium Chloride

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 ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • LIse Tarnow, md

    Steno Diabetes Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2009

Study Completion

July 1, 2010

Last Updated

September 3, 2012

Record last verified: 2012-08

Locations

DK(1)