Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Treprostinil · 2 trials · 2 indications
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).
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module.
PK: Insulin Lispro Cmax (Part B)
PK: Insulin Lispro AUC(0-30min) (Part B)
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 (Part A) | EXPERIMENTAL | Treprostinil administered as a single subcutaneous (SC) bolus injection. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Placebo administered as a single SC bolus injection. |
| LY900014 (Part B) | EXPERIMENTAL | LY900014 (test) administered as a single SC bolus injection. |
| Insulin Lispro (Part B) | ACTIVE_COMPARATOR | Insulin lispro (reference) administered as a single SC bolus injection. |
| Name | Type | Description |
|---|---|---|
| Sodium Citrate | DRUG | Administered SC infusion. |
| Treprostinil | DRUG | Administered SC infusion. |
| Humalog diluent | DRUG | Administered SC infusion. |
| Magnesium Chloride | DRUG | Administered SC infusion. |
| Placebo | DRUG | Administered SC. |
| LY900014 | DRUG | Administered SC. |
| Insulin Lispro | DRUG | Administered SC. |
Inclusion Criteria: * T1D for at least 1 year and continuously using insulin for at least 1 year * Using an insulin pump for at least the last 6 months * Have hemoglobin A1c (HbA1c) value of ≤ 9.0% * Have a body mass index (BMI) within the range of 18.5 to 35.0 kilograms per square meter (kg/m²) * ...
Treprostinil is an investigational small molecule being studied in healthy volunteers and in people with Type 1 Diabetes Mellitus. In clinical trials, it has been evaluated for its effects when given alongside other investigational products. It is not approved and remains in early-stage clinical development.
Treprostinil is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the NYSE under the ticker LLY. The company is conducting Phase 1 clinical trials with this investigational small molecule.
Treprostinil is in Phase 1 clinical development. Two Phase 1 studies have been completed, one in healthy participants and one in participants with Type 1 Diabetes Mellitus. The drug is investigational and has not been approved by regulatory authorities.
Treprostinil has been studied in two completed Phase 1 trials. NCT02770521 enrolled 23 healthy Japanese participants, and NCT05067270 enrolled 40 participants with Type 1 Diabetes Mellitus. Both trials were randomized, double-blind, and placebo-controlled.
Treprostinil is not the same as LY900014. In one clinical trial, NCT02770521, treprostinil was studied alongside a new formulation of LY900014, an investigational product from the same developer. They are separate agents evaluated in the same study.