This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess and compare the effect on blood sugar control of insulin detemir and insulin aspart or insulin detemir alone administered by a insulin pen PDS290 (FlexTouch®) versus a Novo Nordisk marketed insulin pen (FlexPen®) in subjects with type 1 or type 2 diabetes mellitus. Furthermore, the subject's preference of the devices will be investigated by the use of questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.
All subjects to receive insulin detemir treatment (and if relevant insulin aspart) with either a insulin pen PDS290 (FlexTouch®) or a Novo Nordisk marketed insulin pen (FlexPen®) for 12 weeks. After 12 weeks, all subjects will continue their insulin treatment with the other injection device.
Novo Nordisk Investigational Site
Burlingame, California, United States
Novo Nordisk Investigational Site
Concord, California, United States
Novo Nordisk Investigational Site
Encino, California, United States
Novo Nordisk Investigational Site
Escondido, California, United States
Novo Nordisk Investigational Site
Fresno, California, United States
HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®
Time frame: Week 12 of each treatment sequence
Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use
Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)
Time frame: Week 24
Summary Score for Treatment Satisfaction
Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.
Time frame: Week 24
Score for Treatment Impact Measure for Diabetes
Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.
Time frame: Week 24
Clinical Technical Complaints (CTCs)
A clinical technical complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device.
Time frame: Weeks 0-24 (whole trial period)
Number of Hypoglycaemic Episodes
Presented by severity: major: subject not able to treat himself; minor: plasma glucose below 3.1 mmol/L; symptoms only: no plasma glucose measured or above or equal to 3.1 mmol/L.
Time frame: Weeks 0-12 (first treatment) and 12-24 (second treatment)
Number of Adverse Device Effects
Adverse device effects were defined as clinical technical complaints (CTCs) related to an Adverse Event/Serious Adverse Event. This was defined as an adverse unintended reaction to a medical device. This definition includes any event which is caused by an inadequate or incomplete user instruction or guide in the use of the device and any event caused by wrongful use.
Time frame: From randomisation (week 0) and until 7 days after Week 24 (Visit 16)
Hypoglycaemic Episodes, Number of Events Per Subject Day
Time frame: Weeks 0-12 (first treatment) and 12-24 (second treatment)
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Novo Nordisk Investigational Site
Mission Viejo, California, United States
Novo Nordisk Investigational Site
Orange, California, United States
Novo Nordisk Investigational Site
Poway, California, United States
Novo Nordisk Investigational Site
Salinas, California, United States
Novo Nordisk Investigational Site
Santa Monica, California, United States
...and 55 more locations