A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps

Phase 1

Completed

Brief Summary: The main purpose of this study is to compare LY900014 to insulin lispro (Humalog) in participants with type 1 diabetes who are using an insulin pump and have high blood sugar after eating. For each participant, the study will last about two to nine weeks.

Recruitment & Eligibility

Inclusion Criteria

Male or female participants with type 1 diabetes
Body mass index (BMI) between 18.5 and 30.0 kilograms per square meter, inclusive
Hemoglobin A1c (HbA1c) less than or equal to 8.5 percent (%)
Using CSII and stable insulin regimen for at least 3 months prior to inclusion into the trial

Exclusion Criteria

Known or suspected hypersensitivity to investigational medical product(s) or related products
Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomization in this trial
Known slowing of gastric emptying and or gastrointestinal surgery that, in the opinion of the investigator, might change gastrointestinal motility and food absorption
Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (less than 1.5 years) ophthalmologic examination
Widespread subcutaneous lipodystrophy in the abdomen
Current use of any glucose-lowering agents other than insulin within 3 months prior to screening
Chronic or recent use of corticosteroids

Arm && Interventions

Group	Intervention	Description
100 U/mL LY900014	LY900014	100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods.
100 U/mL Insulin Lispro (Humalog)	Insulin Lispro	100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.

Primary Outcome Measures

Name	Time	Method
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Pump Suspension	Day 2: Baseline up to 5 hours after pump suspension	Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 mg/dL.
Time to Recovery From Hyperglycemia Following Administration of LY900014 and Insulin Lispro (Humalog) After Missed Meal Bolus	Day 1: Baseline up to 5 hours after missed meal bolus	Time to Recovery from Hyperglycemia was defined as tPG140 = time to achieve glucose of 140 Milligrams per deciliter (mg/dL).

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog)	Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension	PD: PGmax following administration of LY900014 and insulin lispro (Humalog)
Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog)	Day 1: Baseline up to 5 hours after missed meal bolus and Day 2: Baseline up to 5 hours after pump suspension	PK: Tmax following administration of LY900014 and insulin lispro (Humalog)