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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2; Delivery Systems

Treatments: Other: 19 injections; Drug: sodium chloride 0.9% solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01680328

INS-4011

U1111-1129-4191 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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82 participants in 1 patient group

Different injection speed and volume combinations

Other group

Description:

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.

Treatment:

Drug: sodium chloride 0.9% solution

Other: 19 injections