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

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

Sponsors

Lead Sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date August 2012
Completion Date October 2012
Primary Completion Date October 2012
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Injection Pain (VAS mm) 1 minute (±30 sec) after each injection
Secondary Outcome
Measure Time Frame
Acceptance of Injection Pain After Injection of Different Volumes. 1 minute (±30 seconds) after each injection
Acceptance of Injection Pain After Injection at Different Speeds. 1 minute (±30 sec) after each injection
Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen. 1 minute (±30 seconds) after each injection
Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion 2 minutes (±30sec) after each injection
Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion 2 minutes (±30sec) after each injection
Enrollment 82
Condition
Intervention

Intervention Type: Other

Intervention Name: 19 injections

Description: 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).

Arm Group Label: Different injection speed and volume combinations

Intervention Type: Drug

Intervention Name: sodium chloride 0.9% solution

Description: Solution for injection.

Arm Group Label: Different injection speed and volume combinations

Eligibility

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: 74 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
Facility: Novo Nordisk Investigational Site
Location Countries

Germany

Verification Date

January 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Different injection speed and volume combinations

Type: Other

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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Supportive Care

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov