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| ID | Type | Description | Link |
|---|---|---|---|
| I8B-MC-ITTC | Other Identifier | Eli Lilly and Company | |
| 2021-001987-18 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1:Arm Region,Abdomen 6mm,Buttock,Abdomen 9mm,Thigh | Experimental | 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. |
|
| Sequence 2:Abdomen 6mm,Abdomen 9mm,Arm Region,Thigh,Buttock | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Citrate | Drug | Administered SC infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1: 1 min post bolus. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institut für Stoffwechselforschung | Neuss | North Rhine-Westphalia | 41460 | Germany | ||
| Profil Mainz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36326260 | Derived | Ignaut D, Fukuda T, Bandi R, Ermer M, Stoffel MS, Zijlstra E, Paavola C. An Investigation Into Local Infusion Site Pain After Infusion of Ultra Rapid Lispro Excipients Across Sites and Depths. J Diabetes Sci Technol. 2024 Jul;18(4):920-929. doi: 10.1177/19322968221135217. Epub 2022 Nov 3. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| ||||||||||||||||
| Period 2 |
| ||||||||||||||||
| Period 3 |
| ||||||||||||||||
| Period 4 |
| ||||||||||||||||
| Period 5 |
|
All participants who received at least one Infusion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | All participants who received at least one infusion and had VAS pain scores. | Posted | Geometric Mean | Geometric Coefficient of Variation | millimeter | Day 1: 1 min post bolus. |
|
Up to 9 days
All participants who received at least one infusion. As per the Protocol, adverse events were analyzed by infusion site locations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Given to Arm Region | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site reaction | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 14, 2021 | Nov 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2022 | Nov 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077559 | Sodium Citrate |
| C427248 | treprostinil |
| D015636 | Magnesium Chloride |
| ID | Term |
|---|---|
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
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| Sequence 3:Abdomen 9mm,Thigh,Abdomen 6mm,Buttock,Arm Region | Experimental | 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. |
|
| Sequence 4:Thigh,Buttock,Abdomen 9mm,Arm Region,Abdomen 6mm | Experimental | 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. |
|
| Sequence 5:Buttock,Arm Region,Thigh,Abdomen 6mm,Abdomen 9mm | Experimental | 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. |
|
| Treprostinil | Drug | Administered SC infusion. |
|
| Humalog diluent | Drug | Administered SC infusion. |
|
| Magnesium Chloride | Drug | Administered SC infusion. |
|
| Mainz |
| 55116 |
| Germany |
| Received At Least One Infusion |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received At Least One Infusion |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received At Least One Infusion |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Received At Least One Infusion |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Treatment Given to Thigh |
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. |
| OG002 | Treatment Given to Abdomen (6 mm) | 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. |
| OG003 | Treatment Given to Abdomen (9 mm) | 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. |
| OG004 | Treatment Given to Buttock | 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. |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 5 |
| 40 |
| EG001 | Treatment Given to Thigh | 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. | 0 | 40 | 0 | 40 | 9 | 40 |
| EG002 | Treatment Given to Abdomen (6 mm) | 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. | 0 | 40 | 0 | 40 | 4 | 40 |
| EG003 | Treatment Given to Abdomen (9 mm) | 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. | 0 | 40 | 0 | 40 | 4 | 40 |
| EG004 | Treatment Given to Buttock | 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. | 0 | 40 | 0 | 40 | 3 | 40 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017616 | Magnesium Compounds |
|
|