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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00607737

Acronym

APPLY

Enrollment

Registered

2008-02-06

Start date

2008-01-31

Completion date

2010-07-31

Last updated

2012-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

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

Interventions

DRUGinsulin detemir

3 cutaneous injections

DRUGsaline

3 cutaneous injections

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

DIAGNOSTIC

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
laser doppler blood flow	10 minutes - 7 days

Secondary

Measure	Time frame
clinical signs	10 min - 7 days
insulin detemir specific antibodies	3 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026