A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Phase 1

Completed

Brief Summary: Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.

Recruitment & Eligibility

Inclusion Criteria

Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion Criteria

Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data

Arm && Interventions

Group	Intervention	Description
LY900014	LY900014	T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014.
Insulin Aspart (Fiasp®)	Insulin Aspart	T1DM participants received a single, individualized, SC dose of insulin aspart.
Insulin Lispro (Humalog®)	Insulin Lispro	T1DM participants received a single, individualized, SC dose of insulin lispro.
Insulin Aspart (NovoRapid®)	Insulin Aspart	T1DM participants received a single, individualized, SC dose of insulin aspart.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm	0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose	PK: Insulin Lispro or Insulin Aspart AUC(0-7h)

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)	Time Frame:-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	PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)