The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
LY900027 administered to participants with T1DM using CSII.
Insulin lispro administered to participants with T1DM using CSII.
Profil Institut für Stoffwechselforschung
Neuss, North Rhine-Westphalia, Germany
Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT)
PK: AUC after Bolus Administration Prior to a MMTT
Time frame: Day 1 through Day 10 in each dosing period
PK: Maximum Observed Insulin Lispro Concentration (Cmax)
PK: C PK: Cmax
Time frame: Day 1 through Day 10 in each dosing period
Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion
Time frame: Day 1 through Day 10 in each dosing period
PD: Total Daily Insulin Dose
PD: Total Daily Insulin Dose
Time frame: Day 1 through Day 10 in each dosing period
Duration Until Catheter Failure
Duration Until Catheter Failure
Time frame: Day -1 through Day 10 in each dosing period
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