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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Informed consent obtained before any trial-related activities.

• Type 1 or type 2 diabetes

• Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months

• Body mass index (BMI) between 18.5 and 30.0 kg/m^2 (both included)

• Caucasians

Exclusion Criteria:

• Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit

• Previous participation in this trial. Participation is defined as: screened

• Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening

• Injection of more than 40 units of insulin per injection

• Continuous Subcutaneous Insulin Infusion use within the last 6 months

• Continuous Glucose Monitoring use within the last 6 months

• Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)

• Known active or in-active skin disease in the injection area or that may affect pain perception

• Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)