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

Lise Tarnow

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus

Treatments: Drug: saline; Drug: insulin detemir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00607737

EudraCT 2007-005677-59

APPLY

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

insulin detemir

Treatment:

Drug: insulin detemir

2

Placebo Comparator group

Description:

saline

Treatment:

Drug: saline