Trial Outcomes & Findings for A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity (NCT NCT04007107)
NCT ID: NCT04007107
Last Updated: 2020-08-04
Results Overview
The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimetres (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
103 participants
Primary outcome timeframe
After 1 minute of each injection (Day 1)
Results posted on
2020-08-04
Participant Flow
The trial was conducted at one site in the Netherlands.
Participants were randomised in a 2×2 scheme evenly to 4 sequences (A, B, C and D) of either DV3396 or PDS290 and side of injection (right/left) on abdomen.
Participant milestones
| Measure |
Sequence A: DV3396 (Right) Then PDS290 (Left)
Participants were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence B: DV3396 (Left) Then PDS290 (Right)
Participants were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence C: PDS290 (Right) Then DV3396 (Left)
Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence D: PDS290 (Left) Then DV3396 (Right)
Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
|---|---|---|---|---|
|
Treatment Period 1 (Day 1)
STARTED
|
26
|
26
|
25
|
26
|
|
Treatment Period 1 (Day 1)
Full Analysis Set (FAS)
|
26
|
26
|
25
|
26
|
|
Treatment Period 1 (Day 1)
Safety Analysis Set (SAS)
|
26
|
26
|
25
|
26
|
|
Treatment Period 1 (Day 1)
Per Protocol (PP) Set
|
26
|
25
|
25
|
26
|
|
Treatment Period 1 (Day 1)
COMPLETED
|
26
|
26
|
25
|
26
|
|
Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 1)
STARTED
|
26
|
26
|
25
|
26
|
|
Treatment Period 2 (Day 1)
COMPLETED
|
26
|
25
|
25
|
26
|
|
Treatment Period 2 (Day 1)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence A: DV3396 (Right) Then PDS290 (Left)
Participants were to receive a subcutaneous (s.c.) injection of DV3396 product (0.25 milligrams (mg) of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence B: DV3396 (Left) Then PDS290 (Right)
Participants were to receive an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence C: PDS290 (Right) Then DV3396 (Left)
Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence D: PDS290 (Left) Then DV3396 (Right)
Participants were to receive an s.c. injection of PDS290 product (0.25 mg of semaglutide) on the left side of abdomen (in treatment period 1); followed by an s.c. injection of DV3396 product (0.25 mg of semaglutide) on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
|---|---|---|---|---|
|
Treatment Period 2 (Day 1)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study Comparing the Injection Site Pain Experience After the Injection of 2 Different Solutions of Semaglutide With 2 Different Injection Pens, a Compound for the Treatment of Type 2 Diabetes and Obesity
Baseline characteristics by cohort
| Measure |
Overall Study
n=103 Participants
Participants were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
|
|---|---|
|
Age, Continuous
|
40.9 Years
STANDARD_DEVIATION 18.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islan
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
98 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White + Black or African American
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White + Asian
|
2 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian + Black or African American
|
0 participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: After 1 minute of each injection (Day 1)Population: The per protocol (PP) set included all participants who had received both injections of semaglutide and had completed both intensity of injection site pain assessments.
The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimetres (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed.
Outcome measures
| Measure |
DV3396
n=102 Participants
Participants were to receive a s.c. injection of DV3396 product (0.25 mg of semaglutide) on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
|
PDS290
n=102 Participants
Participants were to receive a s.c. injection of PDS290 product (0.25 mg of semaglutide) on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
|
|---|---|---|
|
Intensity of Injection Site Pain
|
35.1 score on a scale
Standard Deviation 23.1
|
4.4 score on a scale
Standard Deviation 7.5
|
Adverse Events
Overall Study
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study
n=103 participants at risk
Participants were to receive 2 s.c. injections of 0.25 mg semaglutide; 1 each of PDS290 product and DV3396 product from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
14.6%
15/103 • Number of events 15 • Day 1 to Day 28. Results are based on the safety analysis set which included all participants who had received at least 1 injection of semaglutide (included any skin contact with trial product whether the injection was completed or not).
All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset date on or after the day of first injection and no later than 28 days after the day of last injection. The trial was crossover and injections were given only 30 minutes apart. Therefore it was not possible to say which product the AE was related to. Hence, AE data are presented for the overall study.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER