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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of LY900014 on Recovery From Hyperglycemia Compared to Humalog in Subjects With Type 1 Diabetes Mellitus (T1DM) on Continuous Subcutaneous Insulin Infusion

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: LY900014
* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 U/mL LY900014<br>100 units per milliliter (U/mL) LY900014 administered by continuous subcutaneous insulin infusion (CSII) in one of two study periods. | Drug: LY900014<br>* Administered by CSII<br>|
| Active Comparator: 100 U/mL Insulin Lispro (Humalog)<br>100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods. | Drug: Insulin Lispro<br>* Administered by CSII<br>* Other names: LY275585;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (PD): Maximum Observed Plasma Glucose (PGmax) Following Administration of LY900014 and Insulin Lispro (Humalog) | PD: 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 | 
| Pharmacokinetics (PK): Time to Maximum Observed Insulin Lispro Concentration (Tmax) Following Administration of LY900014 and Insulin Lispro (Humalog) | PK: 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 |