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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: LY900014; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT04276207

2019-003493-13 (EudraCT Number)

17277

I8B-MC-ITST (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

100 U/mL LY900014

Experimental group

Description:

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

Treatment:

Drug: LY900014

100 U/mL Insulin Lispro (Humalog)

Active Comparator group

Description:

100 U/mL Insulin Lispro (Humalog) administered by CSII in one of two study periods.

Treatment:

Drug: Insulin Lispro