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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lise Tarnow
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc

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