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
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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 Steno Diabetes Center:

Primary Outcome Measures:
  • laser doppler blood flow [ Time Frame: 10 minutes - 7 days ] [ Designated as safety issue: Yes ]

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

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
Genders Eligible for Study:   Both
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
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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:
No publications provided

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
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Long-Acting
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 06, 2015