Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes (APPLY)
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ClinicalTrials.gov Identifier: NCT00607737 |
Recruitment Status :
Completed
First Posted : February 6, 2008
Last Update Posted : September 3, 2012
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
insulin detemir
|
Drug: insulin detemir
3 cutaneous injections |
Placebo Comparator: 2
saline
|
Drug: saline
3 cutaneous injections |
- laser doppler blood flow [ Time Frame: 10 minutes - 7 days ]
- clinical signs [ Time Frame: 10 min - 7 days ]
- insulin detemir specific antibodies [ Time Frame: 3 months ]

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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

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
Denmark | |
Steno Diabetes Center | |
Gentofte, Denmark, 2820 |
Principal Investigator: | LIse Tarnow, md | Steno Diabetes Center Copenhagen |
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 |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Detemir Hypoglycemic Agents Physiological Effects of Drugs |