A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

Phase 1

Completed

Brief Summary: This study evaluated a blood sugar lowering insulin, LY900014, delivered by an insulin pump continuously under the skin. The study was conducted in participants with type 1 diabetes mellitus to investigate how the human body processed LY900014 and its effect on blood sugar levels when it was delivered via an insulin pump. Side effects and tolerability were be documented.

Recruitment & Eligibility

Inclusion Criteria

Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening
Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
Have venous access sufficient to allow for blood sampling
Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria

Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study
Have previously participated or withdrawn from this study
Have or used to have health problems, laboratory test results, blood pressure or ECG readings that, in the opinion of the doctor, could make it unsafe to participate in the study
Had blood loss of more than 500 milliliters (mL) within the last month

Arm && Interventions

Group	Intervention	Description
LY900014	LY900014	LY900014 delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods
Insulin Lispro	Insulin Lispro	Insulin lispro delivered via an insulin pump as a continuous infusion under the skin with intermittent bolus doses during meals for two 3-day periods

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h])	Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment	PK: Insulin Lispro AUC(0-5h)

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)	Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatment	PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Neuss, Germany