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

Lise Tarnow40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus

Interventions

insulin detemirDRUG

3 cutaneous injections

salineDRUG

3 cutaneous injections

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Steno Diabetes Center

Gentofte Municipality, Denmark

Outcomes

Primary Outcomes

laser doppler blood flow

Time frame: 10 minutes - 7 days

Secondary Outcomes

clinical signs

Time frame: 10 min - 7 days

insulin detemir specific antibodies

Time frame: 3 months

Data from ClinicalTrials.gov

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