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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01680328

First received: August 31, 2012

Last updated: November 7, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 31, 2012

Last Updated Date

November 7, 2012

Start Date ^ICMJE

August 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Injection pain rated on a Visual Analogue Scale (VAS) in millimetres (mm) [ Time Frame: 1 minute (±30 sec) after the injection ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01680328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Acceptance of pain for each injection (including the needle insertions only) as a binary measure [ Time Frame: Measured 1 minute (±30 seconds) after the injections ] [ Designated as safety issue: No ]
Back flow at the injection site measured as absorbed amount of liquid with filter-paper [ Time Frame: Two minutes (±30 sec) after the injection rated according to a liquid scale ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

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

Intervention ^ICMJE

Other: No treatment given

Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of these 19 injections two 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).

Study Arm (s)

No Intervention: Different injection speed and volume combinations

Intervention: Other: No treatment given

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01680328

Other Study ID Numbers ^ICMJE

INS-4011, U1111-1129-4191

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:	Berit Gorsøe Kjeldsen	Novo Nordisk
Study Director:	Marianne Qvist	Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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