A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Biological: LY900014; Biological: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03341299

I8B-MC-ITRV (Other Identifier)

2017-001500-30 (EudraCT Number)

16641

Details and patient eligibility

About

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 kilogram per meter square (kg/m²) to 35.0 kg/m²
• Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
• Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)

Exclusion criteria

• Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
• Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
• Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening.
• Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator.
• Are treated with a CSII (insulin pump)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 4 patient groups

LY900014 Before Meal

Experimental group

Description:

Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.

Treatment:

Biological: LY900014

LY900014 After Meal

Experimental group

Description:

Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.

Treatment:

Biological: LY900014

Insulin Lispro (Humalog) Before Meal

Active Comparator group

Description:

Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.

Treatment:

Biological: Insulin Lispro

Insulin Lispro (Humalog) After Meal

Active Comparator group

Description:

Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.

Treatment:

Biological: Insulin Lispro