Trial Outcomes & Findings for A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus (NCT NCT05067270)
NCT ID: NCT05067270
Last Updated: 2023-10-04
Results Overview
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 1: 1 min post bolus.
Results posted on
2023-10-04
Participant Flow
Participants were randomly assigned to 1 of 5 infusion site sequence below and received the study treatment in each period. Cannulas were inserted into each of the designated infusion sites (6 millimeter (mm) for all the sites. Additionally for the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen).
Participant milestones
| Measure |
Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh
Participants received 15 millimolar (mM) sodium citrate and 1 microgram per milliliter (μg/mL) treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution as subcutaneous (SC) infusion at the first infusion site at a basal infusion rate of 1 unit per hour (U/h). The same procedure occurred at subsequent infusion sites with an approximately 30-minute (min) interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Period 1: Arm region; Period 2: Abdomen 6mm; Period 3: Buttock; Period 4: Abdomen 9mm; Period 5: Thigh.
|
Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution as SC infusion at the first infusion site at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Period 1: Abdomen 6mm; Period 2: Abdomen 9mm; Period 3: Arm region; Period 4: Thigh; Period 5: Buttock.
|
Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution as SC infusion at the first infusion site at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Period 1: Abdomen 9mm; Period 2: Thigh; Period 3: Abdomen 6mm; Period 4: Buttock; Period 5: Arm region.
|
Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution as SC infusion at the first infusion site at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Period 1: Thigh; Period 2: Buttock; Period 3: Abdomen 9mm; Period 4: Arm Region; Period 5: Abdomen 6mm.
|
Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution as SC infusion at the first infusion site at a basal infusion rate of 1 U/h. The same procedure occurred at subsequent infusion sites with an approximately 30-minute interval between each initiation. Approximately 3, 6, and 9 hours after the start of the basal infusion, a bolus dose of 15 U was delivered at quick bolus speed (15 U/min) to each infusion site according to the treatment sequence with an approximately 30-minute interval between infusion sites.
Period 1: Buttock; Period 2: Arm region; Period 3: Thigh; Period 4: Abdomen 6mm; Period 5: Abdomen 9mm.
|
|---|---|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Period 1
Received At Least One Infusion
|
8
|
8
|
8
|
8
|
8
|
|
Period 1
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Period 2
Received At Least One Infusion
|
8
|
8
|
8
|
8
|
8
|
|
Period 2
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Period 3
Received At Least One Infusion
|
8
|
8
|
8
|
8
|
8
|
|
Period 3
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 4
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Period 4
Received At Least One Infusion
|
8
|
8
|
8
|
8
|
8
|
|
Period 4
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Period 5
STARTED
|
8
|
8
|
8
|
8
|
8
|
|
Period 5
Received At Least One Infusion
|
8
|
8
|
8
|
8
|
8
|
|
Period 5
COMPLETED
|
8
|
8
|
8
|
8
|
8
|
|
Period 5
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Overall
n=40 Participants
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion.
Six mm cannula was inserted into each of the designated areas (arm, abdomen, thigh, and buttock). At the abdominal area only, a 9 mm cannula was also inserted into the opposite side of the lower abdomen.
|
|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: 1 min post bolus.Population: All participants who received at least one infusion and had VAS pain scores.
The Infusion site pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).
Outcome measures
| Measure |
Treatment Given to Arm Region
n=38 Participants
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion to the arm.
|
Treatment Given to Thigh
n=37 Participants
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion to thigh.
|
Treatment Given to Abdomen (6 mm)
n=39 Participants
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion through a 6mm cannula to the abdomen.
|
Treatment Given to Abdomen (9 mm)
n=40 Participants
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion through a 9 mm cannula to the abdomen.
|
Treatment Given to Buttock
n=39 Participants
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion to the buttock.
|
|---|---|---|---|---|---|
|
Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
1 min post bolus (Bolus time: 3 hours)
|
3.4 millimeter
Geometric Coefficient of Variation 182
|
2.0 millimeter
Geometric Coefficient of Variation 119
|
1.8 millimeter
Geometric Coefficient of Variation 112
|
1.9 millimeter
Geometric Coefficient of Variation 119
|
2.4 millimeter
Geometric Coefficient of Variation 167
|
|
Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
1 min post bolus (Bolus time: 6 hours)
|
3.7 millimeter
Geometric Coefficient of Variation 164
|
2.6 millimeter
Geometric Coefficient of Variation 137
|
2.3 millimeter
Geometric Coefficient of Variation 151
|
2.0 millimeter
Geometric Coefficient of Variation 113
|
3.3 millimeter
Geometric Coefficient of Variation 161
|
|
Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
1 min post bolus (Bolus time: 9 hours)
|
4.8 millimeter
Geometric Coefficient of Variation 211
|
3.4 millimeter
Geometric Coefficient of Variation 155
|
2.5 millimeter
Geometric Coefficient of Variation 141
|
2.4 millimeter
Geometric Coefficient of Variation 141
|
3.8 millimeter
Geometric Coefficient of Variation 196
|
Adverse Events
Treatment Given to Arm Region
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment Given to Thigh
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Treatment Given to Abdomen (6 mm)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment Given to Abdomen (9 mm)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment Given to Buttock
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Given to Arm Region
n=40 participants at risk
Participants who received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion to the arm region.
|
Treatment Given to Thigh
n=40 participants at risk
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion to thigh.
|
Treatment Given to Abdomen (6 mm)
n=40 participants at risk
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion through a 6mm cannula to the abdomen.
|
Treatment Given to Abdomen (9 mm)
n=40 participants at risk
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion through a 9 mm cannula to the abdomen.
|
Treatment Given to Buttock
n=40 participants at risk
Participants received 15 mM sodium citrate and 1 μg/mL treprostinil in humalog diluent with 5 mM magnesium chloride (without insulin) as SC infusion to the buttock.
|
|---|---|---|---|---|---|
|
General disorders
Infusion site reaction
|
12.5%
5/40 • Number of events 5 • Up to 9 days
All participants who received at least one infusion. As per the Protocol, adverse events were analyzed by infusion site locations.
|
22.5%
9/40 • Number of events 9 • Up to 9 days
All participants who received at least one infusion. As per the Protocol, adverse events were analyzed by infusion site locations.
|
10.0%
4/40 • Number of events 4 • Up to 9 days
All participants who received at least one infusion. As per the Protocol, adverse events were analyzed by infusion site locations.
|
10.0%
4/40 • Number of events 4 • Up to 9 days
All participants who received at least one infusion. As per the Protocol, adverse events were analyzed by infusion site locations.
|
7.5%
3/40 • Number of events 3 • Up to 9 days
All participants who received at least one infusion. As per the Protocol, adverse events were analyzed by infusion site locations.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60