Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

October 31, 2026

Conditions
Diabetes Mellitus, Type 1Type 1 Diabetes Mellitus
Interventions
DRUG

Diluted Humalog U-200 Insulin

Commercially available U-200 Humalog (insulin lispro) diluted 1:1 with a dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration. Administered as single subcutaneous injection at 0.20 u/kg body weight following mixed meal consumption.

DRUG

Diluted U-500 Humulin Insulin

Commercially available U-500 Humulin (regular insulin) diluted 1:4 with dilution buffer composed of sterile water, EDTA and mannitol to achieve U-100 concentration. Administered as single subcutaneous injection at 0.20 u/kg body weight following mixed meal consumption.

DRUG

Lyumjev U-100 Insulin

Commercially available U-100 Lyumjev (insulin lispro-aabc) administered unmodified as comparator. Administered as single subcutaneous injection at 0.20 u/kg body weight following mixed meal consumption.

DIETARY_SUPPLEMENT

Boost Mixed Meal Test

Standardized mixed meal (Boost drink) administered at 8.0 mL/kg body weight (17.3 g carbohydrates per 100 mL) consumed immediately before insulin injection at each visit.

All Listed Sponsors
lead

Stanford University

OTHER