Trial Outcomes & Findings for Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics (NCT NCT00773279)
NCT ID: NCT00773279
Last Updated: 2017-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
242 participants
Primary outcome timeframe
Week 12 of each treatment sequence
Results posted on
2017-03-27
Participant Flow
The trial was conducted at 61 sites in the United States of America (USA).
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.
Participant milestones
| Measure |
PDS290 -> FlexPen®
|
FlexPen® -> PDS290
|
|---|---|---|
|
Period 1
STARTED
|
121
|
121
|
|
Period 1
COMPLETED
|
114
|
117
|
|
Period 1
NOT COMPLETED
|
7
|
4
|
|
Period 2
STARTED
|
114
|
117
|
|
Period 2
COMPLETED
|
111
|
111
|
|
Period 2
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
PDS290 -> FlexPen®
|
FlexPen® -> PDS290
|
|---|---|---|
|
Period 1
Adverse Event
|
2
|
1
|
|
Period 1
Lack of Efficacy
|
0
|
2
|
|
Period 1
Unclassified
|
5
|
1
|
|
Period 2
Adverse Event
|
0
|
1
|
|
Period 2
Lack of Efficacy
|
1
|
0
|
|
Period 2
Protocol Violation
|
0
|
3
|
|
Period 2
Unclassified
|
2
|
2
|
Baseline Characteristics
Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics
Baseline characteristics by cohort
| Measure |
Entire Trial Population
n=242 Participants
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.
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 13.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
226 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
199 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
242 participants
n=93 Participants
|
|
HbA1c (glycosylated haemoglobin)
|
7.3 percentage (%) of total haemoglobin
STANDARD_DEVIATION 0.9 • n=93 Participants
|
PRIMARY outcome
Timeframe: Week 12 of each treatment sequencePopulation: Intention-to-treat (ITT) population comprising all randomised subjects and with data on HbA1c. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects dropped out during either treatment sequence.
Outcome measures
| Measure |
PDS290
n=232 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=233 Participants
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
HbA1c (Glycosylated Haemoglobin) for Participants Treated With PDS290 and FlexPen®
|
7.5 percentage (%) of total haemoglobin
Standard Deviation 1.0
|
7.5 percentage (%) of total haemoglobin
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Week 24Population: ITT population. Some subjects did not have any available Niskanen Comparative Device Questionnaire results.
Questionnaire (Niskanen Comparative Device Questionnaire) compared preference / convenience and ease of use by device specific questionnaire (summarised by scores of question 9)
Outcome measures
| Measure |
PDS290
n=227 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use
Preference of PDS290
|
68 percentage of participants
|
—
|
|
Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use
Preference of FlexPen®
|
19 percentage of participants
|
—
|
|
Percentage of Subject Having Preference for PDS290 Versus FlexPen® in Terms of Convenience and Ease of Use
No preference
|
13 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available ITSQ results in PDS290 and FlexPen® treatment groups, respectively.
Overall summary from Insulin Treatment Satisfaction Questionnaire (ITSQ) with higher scores (0-100) indicating greater satisfaction.
Outcome measures
| Measure |
PDS290
n=222 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=223 Participants
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Summary Score for Treatment Satisfaction
|
80.9 scores on a scale
Standard Deviation 11.3
|
76.8 scores on a scale
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: Week 24Population: ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any TRIM-D available results in PDS290 and FlexPen® treatment groups, respectively.
Treatment Related Impact Measure for Diabetes (TRIM-D and TRIM-D device) with scores from 0-100, higher scores indicate less treatment related impact.
Outcome measures
| Measure |
PDS290
n=232 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=232 Participants
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Score for Treatment Impact Measure for Diabetes
TRIM-D total scores
|
75.1 scores on a scale
Standard Deviation 13.1
|
72.8 scores on a scale
Standard Deviation 13.6
|
|
Score for Treatment Impact Measure for Diabetes
TRIM-D device scores
|
84.9 scores on a scale
Standard Deviation 12.7
|
78.6 scores on a scale
Standard Deviation 16.6
|
SECONDARY outcome
Timeframe: Weeks 0-24 (whole trial period)Population: ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.
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.
Outcome measures
| Measure |
PDS290
n=242 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=242 Participants
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Clinical Technical Complaints (CTCs)
|
67 CTCs
|
84 CTCs
|
SECONDARY outcome
Timeframe: Weeks 0-12 (first treatment) and 12-24 (second treatment)Population: ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.
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.
Outcome measures
| Measure |
PDS290
n=239 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=235 Participants
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Number of Hypoglycaemic Episodes
All episodes
|
1108 episodes
|
1092 episodes
|
|
Number of Hypoglycaemic Episodes
Major episodes
|
7 episodes
|
3 episodes
|
|
Number of Hypoglycaemic Episodes
Minor episodes
|
920 episodes
|
927 episodes
|
|
Number of Hypoglycaemic Episodes
Symptoms only
|
181 episodes
|
162 episodes
|
SECONDARY outcome
Timeframe: From randomisation (week 0) and until 7 days after Week 24 (Visit 16)Population: ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®). Some subjects did not have any available results in PDS290 and FlexPen® treatment groups, respectively.
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.
Outcome measures
| Measure |
PDS290
n=239 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=235 Participants
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Number of Adverse Device Effects
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Weeks 0-12 (first treatment) and 12-24 (second treatment)Population: ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
Outcome measures
| Measure |
PDS290
n=239 Participants
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=235 Participants
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Hypoglycaemic Episodes, Number of Events Per Subject Day
|
0.06 events per subject-day
|
0.06 events per subject-day
|
Adverse Events
PDS290
Serious events: 7 serious events
Other events: 25 other events
Deaths: 0 deaths
FlexPen®
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PDS290
n=238 participants at risk
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=235 participants at risk
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/238 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.43%
1/235 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.42%
1/238 • Number of events 2 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.43%
1/235 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/238 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.43%
1/235 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/238 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.43%
1/235 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/238 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.43%
1/235 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/238 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.43%
1/235 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Injury, poisoning and procedural complications
Drug dispensing error
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Cardiac disorders
Cardiac Failure
|
0.42%
1/238 • Number of events 1 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
0.00%
0/235 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
Other adverse events
| Measure |
PDS290
n=238 participants at risk
Participants who received usual insulin treatment with pre-filled pen device PDS290 (FlexTouch®).
|
FlexPen®
n=235 participants at risk
Participants who received usual insulin treatment with pre-filled pen device FlexPen®.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.3%
15/238 • Number of events 19 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
8.5%
20/235 • Number of events 24 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.6%
11/238 • Number of events 12 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
5.1%
12/235 • Number of events 13 • From randomisation and until seven days after Week 24 (Visit 16).
ITT population. This was a cross-over trial, so subjects received treatment with both PDS290 and FlexPen®. Results are reported separately for each treatment period, i.e. PDS290 versus FlexPen®).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right not to release data until specified milestones, eg a clinical trial report is available. This includes the right not to release interim results from clinical trials, because such results may lead to conclusions that are later shown to be incorrect. Novo Nordisk will not suppress or veto publications; however Novo Nordisk reserves the right to postpone publication and/or communication for a short time to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER