A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Phase 1

Completed

Brief Summary: The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Recruitment & Eligibility

Inclusion Criteria

Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Exclusion Criteria

Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
More than one episode of severe hypoglycaemia in the last 6 months
Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
Have obvious clinical signs or symptoms of liver disease
Have a history of renal impairment

Arm && Interventions

Group	Intervention	Description
LY900014-Part A	LY900014	Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.
Humalog (Insulin Lispro)-Part A	Insulin Lispro	Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.
LY900014-Part B	LY900014	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump.
Humalog (Insulin Lispro)-Part B	Insulin Lispro	Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part	Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes postdose	Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC(0 -7h)) following Each Treatment Arm for Each Study Part.

Secondary Outcome Measures

Name	Time	Method
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part	-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240 and 300 minutes postdose	Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve (BG∆AUC(0-5h)) Following Each Treatment Arm for Each Study Part.