A Phase 1 interventional study of Sodium Citrate and Treprostinil in Type 1 Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 2 sites in Germany. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2023-10-04.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The main purpose of this study is to evaluate the effect of excipients sodium citrate and treprostinil without insulin on local infusion site pain in participants with type 1 diabetes mellitus (T1DM) on continuous subcutaneous insulin infusion (CSII). The study may last up to 36 days including a screening period and 3 visits.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants had cannulas 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), and the first infusion site was initiated subcutaneously (SC) with 15 millimolar (mM) sodium citrate and 1 microgram per milliliter (μg/mL) treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution 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.
Drug: Sodium Citrate · Drug: Treprostinil · Drug: Humalog diluent · Drug: Magnesium Chloride
Participants had cannulas inserted into each of the designated infusion sites (6 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), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution 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.
Drug: Sodium Citrate · Drug: Treprostinil · Drug: Humalog diluent · Drug: Magnesium Chloride
Participants had cannulas inserted into each of the designated infusion sites (6 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), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution 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.
Drug: Sodium Citrate · Drug: Treprostinil · Drug: Humalog diluent · Drug: Magnesium Chloride
Participants had cannulas inserted into each of the designated infusion sites (6 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), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution at a basal infusion rate of 1 units per 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.
Drug: Sodium Citrate · Drug: Treprostinil · Drug: Humalog diluent · Drug: Magnesium Chloride
Participants had cannulas inserted into each of the designated infusion sites (6 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), and the first infusion site was initiated with 15 mM sodium citrate and 1 μg/mL treprostinil in Humalog diluent with 5 mM magnesium chloride (without insulin) solution 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.
Drug: Sodium Citrate · Drug: Treprostinil · Drug: Humalog diluent · Drug: Magnesium Chloride
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Administered SC infusion.
Visual Analog Scale (VAS) Pain Score in the Abdominal, Arm, Thigh, and Buttock Areas
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).
Time frame: Day 1: 1 min post bolus.
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).
| Milestone | Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh | Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock | Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region | Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm | Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm |
|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 |
| Received at least one infusion | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh | Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock | Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region | Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm | Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm |
|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 |
| Received at least one infusion | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh | Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock | Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region | Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm | Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm |
|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 |
| Received at least one infusion | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh | Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock | Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region | Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm | Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm |
|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 |
| Received at least one infusion | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh | Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock | Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region | Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm | Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm |
|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 |
| Received at least one infusion | 8 | 8 | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
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).
| millimeter | Treatment Given to Arm Region | Treatment Given to Thigh | Treatment Given to Abdomen (6 mm) | Treatment Given to Abdomen (9 mm) | Treatment Given to Buttock |
|---|---|---|---|---|---|
| 1 min post bolus (Bolus time: 3 hours) | 3.4 ± 182 | 2.0 ± 119 | 1.8 ± 112 | 1.9 ± 119 | 2.4 ± 167 |
| 1 min post bolus (Bolus time: 6 hours) | 3.7 ± 164 | 2.6 ± 137 | 2.3 ± 151 | 2.0 ± 113 | 3.3 ± 161 |
| 1 min post bolus (Bolus time: 9 hours) | 4.8 ± 211 | 3.4 ± 155 | 2.5 ± 141 | 2.4 ± 141 | 3.8 ± 196 |
Collected over Up to 9 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Given to Arm Region | 0/40 (0%) | 0/40 (0%) | 5/40 (12.5%) |
| Treatment Given to Thigh | 0/40 (0%) | 0/40 (0%) | 9/40 (22.5%) |
| Treatment Given to Abdomen (6 mm) | 0/40 (0%) | 0/40 (0%) | 4/40 (10%) |
| Treatment Given to Abdomen (9 mm) | 0/40 (0%) | 0/40 (0%) | 4/40 (10%) |
| Treatment Given to Buttock | 0/40 (0%) | 0/40 (0%) | 3/40 (7.5%) |
| Event | Treatment Given to Arm Region | Treatment Given to Thigh | Treatment Given to Abdomen (6 mm) | Treatment Given to Abdomen (9 mm) | Treatment Given to Buttock |
|---|---|---|---|---|---|
| Infusion site reactionGeneral disorders | 5/40 | 9/40 | 4/40 | 4/40 | 3/40 |
All participants who received at least one Infusion.
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 40.5 ± 12.0 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 10 |
| Male | 30 |
| Race (NIH/OMB)(Participants) | Overall |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 40 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Overall |
|---|---|
| Germany | 40 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Eli Lilly and Company