This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Administered subcutaneously (SC)
Pharmacokinetics (PK): Area under the Concentration Curve (AUC) of Insulin Lispro
PK: AUC of Insulin Lispro
Time frame: Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period
Pharmacodynamics (PD): AUC of Glucose Following a Meal
PD: AUC of Glucose Following a Meal
Time frame: Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period
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