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 A/S
ClinicalTrials.gov Identifier:
NCT01680328
First received: August 31, 2012
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: December 6, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Interventions: Other: 19 injections
Drug: sodium chloride 0.9% solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted at a single site in Germany at a single visit.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Participants Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.

Participant Flow:   Overall Study
    All Participants  
STARTED     82  
Subjects Missing Injections     2 [1]
COMPLETED     80  
NOT COMPLETED     2  
[1] One missed the [1600 μL, 450 μL/s; thighs]; one missed the [400 μL, 300 μL/s; abdomen]



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  82  
Age  
[units: years]
Mean ± Standard Deviation
  54.3  ± 11.9  
Gender  
[units: participants]
 
Female     32  
Male     50  



  Outcome Measures
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1.  Primary:   Injection Pain (VAS mm)   [ Time Frame: 1 minute (±30 sec) after each injection ]

2.  Secondary:   Acceptance of Injection Pain After Injection of Different Volumes.   [ Time Frame: 1 minute (±30 seconds) after each injection ]

3.  Secondary:   Acceptance of Injection Pain After Injection at Different Speeds.   [ Time Frame: 1 minute (±30 sec) after each injection ]

4.  Secondary:   Acceptance of Injection Pain After Injection in the Thighs Versus Abdomen.   [ Time Frame: 1 minute (±30 seconds) after each injection ]

5.  Secondary:   Estimated Mean Differences in the Volume of Backflow (uL) in the Abdomen After Different Injection Volumes and Speeds as Compared to Needle Insertion   [ Time Frame: 2 minutes (±30sec) after each injection ]

6.  Secondary:   Estimated Mean Differences in the Volume of Backflow (uL) in the Thighs After Different Injection Volumes and Speeds as Compared to Needle Insertion   [ Time Frame: 2 minutes (±30sec) after each injection ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
e-mail: clinicaltrials@novonordisk.com


No publications provided


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01680328     History of Changes
Other Study ID Numbers: INS-4011, U1111-1129-4191
Study First Received: August 31, 2012
Results First Received: December 6, 2013
Last Updated: May 19, 2014
Health Authority: Germany: Institutional Ethics Committee