NCT01680328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

June 19, 2014

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

August 31, 2012

Results QC Date

December 6, 2013

Last Update Submit

January 18, 2017

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Injection Pain (VAS mm)

    Calculated as the least square mean estimate of the difference in injection pain on a VAS (mm) between different factor levels corresponding to injection region, injection volume and injection speed (pain was assessed using an electronic VAS consisting of a 100 mm line where 0 mm corresponded to no pain and 100 mm corresponded to worst pain. After each injection, the subjects rated their pain perception at the electronic VAS by marking the 100 mm line).

    1 minute (±30 sec) after each injection

Secondary Outcomes (5)

  • 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

Study Arms (1)

Different injection speed and volume combinations

OTHER

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.

Other: 19 injectionsDrug: sodium chloride 0.9% solution

Interventions

19 injectionsOTHER

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).

Different injection speed and volume combinations
sodium chloride 0.9% solutionDRUG

Solution for injection.

Different injection speed and volume combinations

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

  • Heise T, Nosek L, Dellweg S, Zijlstra E, Praestmark KA, Kildegaard J, Nielsen G, Sparre T. Impact of injection speed and volume on perceived pain during subcutaneous injections into the abdomen and thigh: a single-centre, randomized controlled trial. Diabetes Obes Metab. 2014 Oct;16(10):971-6. doi: 10.1111/dom.12304. Epub 2014 May 11.

    PMID: 24720741RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

Sodium ChlorideSolutions

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsPharmaceutical Preparations

Results Point of Contact

Title
Public Access to Clinical Trials
Organization
Novo Nordisk A/S
clinicaltrials@novonordisk.com

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 7, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

March 3, 2017

Results First Posted

June 19, 2014

Record last verified: 2017-01

Locations

DE(1)