NCT01680328

Investigation of Pain During Subcutaneous Injections With Different Injection Speed and Volume Combinations

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to assess and describe the pain in relation to subcutaneous (under the skin) injection of different combinations of injection speed and volume with respect to acceptance of the injection pain and backflow.

Conditions

• Diabetes
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Delivery Systems

Interventions

Type	Name	Description
OTHER	19 injections	Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).
DRUG	sodium chloride 0.9% solution	Solution for injection.

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2012-09-07
• Last updated: 2017-03-03
• Results posted: 2014-06-19

Locations

1 site across 1 country: Germany