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OpenTrials
Completed

NCT Number: NCT00607737

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

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Steno Diabetes Center

Gentofte Municipality, 2820, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

3 cutaneous injections

Saline

Drug

3 cutaneous injections

Primary outcomes

  1. laser doppler blood flow

    Time frame: 10 minutes - 7 days

Secondary outcomes

  1. clinical signs

    Time frame: 10 min - 7 days

  2. insulin detemir specific antibodies

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Lise Tarnow

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: APPLY

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Feb 6, 2008
Registry last updated
Sep 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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