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

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: saline; Drug: insulin detemir

• Registration Number: NCT00607737
• Lead Sponsor: Lise Tarnow

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-02-05
• Study First Posted: 2008-02-06
• Primary Completion: 2009-06
• Study Completion: 2010-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-31
• Last Update Posted: 2012-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	saline	saline
1	insulin detemir	insulin detemir

Primary Outcome Measures

Name	Time	Method
laser doppler blood flow	10 minutes - 7 days

Secondary Outcome Measures

Name	Time	Method
insulin detemir specific antibodies	3 months
clinical signs	10 min - 7 days

Trial Locations

Locations (1)

Steno Diabetes Center; 🇩🇰 Gentofte, Denmark