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Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773279
First Posted: October 16, 2008
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
Results First Submitted: October 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Delivery Systems
Interventions: Device: FlexTouch®
Device: FlexPen®

  Participant Flow
  Hide Participant Flow

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 61 sites in the United States of America (USA).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening period of 2 weeks where the subjects were assessed for eligibility, run-in period of 6 weeks, hereafter eligible subjects were randomised to one of the two 12-week treatment sequences: PDS290 -> FlexPen® or FlexPen® -> PDS290.

Reporting Groups
  Description
PDS290 -> FlexPen® No text entered.
FlexPen® -> PDS290 No text entered.

Participant Flow for 2 periods

Period 1:   Period 1
    PDS290 -> FlexPen®   FlexPen® -> PDS290
STARTED   121   121 
COMPLETED   114   117 
NOT COMPLETED   7   4 
Adverse Event                2                1 
Lack of Efficacy                0                2 
Unclassified                5                1 

Period 2:   Period 2
    PDS290 -> FlexPen®   FlexPen® -> PDS290
STARTED   114   117 
COMPLETED   111   111 
NOT COMPLETED   3   6 
Adverse Event                0                1 
Lack of Efficacy                1                0 
Protocol Violation                0                3 
Unclassified                2                2 



  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
Entire Trial Population Participants who in random order received usual insulin treatment with pre-filled pen device PDS290 for 12 weeks followed by switch to pre-filled pen device FlexPen® for 12 weeks or vice versa. The frequency of basal and bolus injections were kept the same throughout the trial. Both prefilled pens were self-administered subcutaneously by the participants.

Baseline Measures
   Entire Trial Population 
Overall Participants Analyzed 
[Units: Participants]
 242 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (13.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      95  39.3% 
Male      147  60.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      16   6.6% 
Not Hispanic or Latino      226  93.4% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      1   0.4% 
Asian      7   2.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      29  12.0% 
White      199  82.2% 
More than one race      0   0.0% 
Unknown or Not Reported      6   2.5% 
Region of Enrollment 
[Units: Participants]
 
United States   242 
HbA1c (glycosylated haemoglobin) 
[Units: Percentage (%) of total haemoglobin]
Mean (Standard Deviation)
 7.3  (0.9) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®   [ Time Frame: Week 12 of each treatment sequence ]

2.  Secondary:   Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use   [ Time Frame: Week 24 ]

3.  Secondary:   Summary Score for Treatment Satisfaction   [ Time Frame: Week 24 ]

4.  Secondary:   Score for Treatment Impact Measure for Diabetes   [ Time Frame: Week 24 ]

5.  Secondary:   Clinical Technical Complaints (CTCs)   [ Time Frame: Weeks 0-24 (whole trial period) ]

6.  Secondary:   Number of Hypoglycaemic Episodes   [ Time Frame: Weeks 0-12 (first treatment) and 12-24 (second treatment) ]

7.  Secondary:   Number of Adverse Device Effects   [ Time Frame: From randomisation (week 0) and until 7 days after Week 24 (Visit 16) ]

8.  Secondary:   Hypoglycaemic Episodes, Number of Events Per Subject Day   [ Time Frame: Weeks 0-12 (first treatment) and 12-24 (second treatment) ]


  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
No text entered.


  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


Publications of Results:


Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00773279     History of Changes
Other Study ID Numbers: PDS290-1971
First Submitted: October 14, 2008
First Posted: October 16, 2008
Results First Submitted: October 12, 2015
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017