Trial Outcomes & Findings for Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units (NCT NCT01334606)
NCT ID: NCT01334606
Last Updated: 2022-03-10
Results Overview
The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
3 weeks per pen needle
Results posted on
2022-03-10
Participant Flow
Recruitment began at three medical research centers in March 2011. Due to slow enrolment, the study was terminated after 9 weeks.
There is no information for this section.
Participant milestones
| Measure |
All Study Participants
Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
All Study Participants
Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared.
|
|---|---|
|
Overall Study
Study Terminated due to slow enrolment
|
18
|
Baseline Characteristics
Evaluation of a 4mmx32G Pen Needle for Injection of Basal Insulin Doses Above 40 Units
Baseline characteristics by cohort
| Measure |
All Study Participants
n=21 Participants
This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention.
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 9.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks per pen needlePopulation: No analysis was performed. The study was terminated due to slow enrollment. The same endpoint was studied and reported in a similar subject population, including Lantus users, in study DBC-11-SQUIR05(NCT01231984)which had a similar design.
The measure of glycemic control will be the percent difference in FRU assessed at the end of Period 1 compared to FRU assessed at the end of Period 2. The average percent difference in FRU between the Nano and Short pen needles, with the Short as a reference, must be shown to be no more than +/- 20% with 95% confidence. General linear models will be used, adjusting for baseline FRU. This outcome measure was to be determined for the total subject population as well as for the subset of Lantus users.
Outcome measures
Outcome data not reported
Adverse Events
All Study Participants
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
4mmx32G Pen Needle
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
8mmx31G Pen Needle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Study Participants
n=21 participants at risk
This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product.
|
4mmx32G Pen Needle
n=21 participants at risk
Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2
|
8mmx31G Pen Needle
n=21 participants at risk
Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Progressive Degeneration right knee
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
0.00%
0/21 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
Other adverse events
| Measure |
All Study Participants
n=21 participants at risk
This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product.
|
4mmx32G Pen Needle
n=21 participants at risk
Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2
|
8mmx31G Pen Needle
n=21 participants at risk
Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Tennis Elbow
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
0.00%
0/21 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
0.00%
0/21 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
|
Endocrine disorders
hypoglycemia
|
28.6%
6/21 • Number of events 15 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
23.8%
5/21 • Number of events 12 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
0.00%
0/21 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
|
Renal and urinary disorders
urinary tract infection
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
0.00%
0/21 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
0.00%
0/21 • Adverse Events were collected from the start of study participation until subjects completed, or were discontinued from the study. Subjects that participated in the study used each pen needle for up to 3 weeks.
|
Additional Information
Laurence J. Hirsch. Medical Director
BD Medical - Diabetes Care
Phone: 201-847-6513
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60