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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607737
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : September 3, 2012
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center Copenhagen

Study Description
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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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: insulin detemir Drug: saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
insulin detemir
 Drug: insulin detemir
3 cutaneous injections
Placebo Comparator: 2
saline
 Drug: saline
3 cutaneous injections


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

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

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

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607737


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

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Responsible Party: Lise Tarnow, professor, Steno Diabetes Center Copenhagen
ClinicalTrials.gov Identifier: NCT00607737    
Other Study ID Numbers: APPLY
EudraCT 2007-005677-59
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs