This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center Identifier:
First received: January 23, 2008
Last updated: August 31, 2012
Last verified: August 2012

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

Condition Intervention Phase
Diabetes Mellitus Drug: insulin detemir Drug: saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:

Further study details as provided by Lise Tarnow, Steno Diabetes Center:

Primary Outcome Measures:
  • laser doppler blood flow [ Time Frame: 10 minutes - 7 days ]

Secondary Outcome Measures:
  • clinical signs [ Time Frame: 10 min - 7 days ]
  • insulin detemir specific antibodies [ Time Frame: 3 months ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: July 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
insulin detemir
Drug: insulin detemir
3 cutaneous injections
Placebo Comparator: 2
Drug: saline
3 cutaneous injections


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00607737

Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Lise Tarnow
Novo Nordisk A/S
Principal Investigator: LIse Tarnow, md Steno Diabetes Center
  More Information

Additional Information:
Responsible Party: Lise Tarnow, professor, Steno Diabetes Center Identifier: NCT00607737     History of Changes
Other Study ID Numbers: APPLY
EudraCT 2007-005677-59
Study First Received: January 23, 2008
Last Updated: August 31, 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 20, 2017