Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Humalog diluent · 1 trial · 1 indication
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).
| 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. |
| 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. |
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) * ...
Humalog diluent is an investigational small molecule developed by Eli Lilly and Company for use in type 1 diabetes mellitus. It is being studied in a Phase 1 clinical trial to evaluate infusion site pain after infusion of excipients in participants with type 1 diabetes. The trial has been completed.
Humalog diluent is being studied for use in type 1 diabetes mellitus. The Phase 1 trial evaluated infusion site pain after infusion of excipients in participants with type 1 diabetes. It is not approved for this or any other indication and remains investigational.
Humalog diluent is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Eli Lilly is the sponsor of the clinical program for this investigational small molecule in type 1 diabetes mellitus.
Humalog diluent is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for any indication.
Humalog diluent has been studied in one completed Phase 1 trial, NCT05067270, titled A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus. The trial enrolled 40 participants in Germany and was randomized, double-blind, and controlled.