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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00607737
First received: January 23, 2008
Last updated: August 31, 2012
Last verified: August 2012
  Purpose

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
saline
Drug: saline
3 cutaneous injections

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00607737

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

Additional Information:
No publications provided

Responsible Party: Lise Tarnow, professor, Steno Diabetes Center
ClinicalTrials.gov 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014