Conditions: Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Delivery Systems
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 82
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: The study consists of 80 treatment arms in a cross-over design with 19 treatments and 19 periods. The 80 treatment arms will represent different orders of the 19 treatments and each treatment arm will be used for one subject. A subject not completing all treatments will be replaced by another subject using the same treatment arm.

Interventions: intervention 1: 19 injections intervention 2: sodium chloride 0.9% solution
Intervention descriptions: intervention 1: 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). intervention 2: Solution for injection.

Protocol document: