Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes (APPLY)

August 31, 2012 updated by: Lise Tarnow

Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2820
        • Steno Diabetes center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
saline
Drug: saline
3 cutaneous injections
Experimental: 1
insulin detemir
Drug: insulin detemir
3 cutaneous injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
laser doppler blood flow
Time Frame: 10 minutes - 7 days
10 minutes - 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical signs
Time Frame: 10 min - 7 days
10 min - 7 days
insulin detemir specific antibodies
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lise Tarnow

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: LIse Tarnow, md, Steno Diabetes Center Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

February 5, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 31, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPLY
  • EudraCT 2007-005677-59

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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