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

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin Aspart; Drug: LY900014; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03449433

I8B-MC-ITSL (Other Identifier)

16911

2017-003459-47 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 5 patient groups

LY900014

Experimental group

Description:

T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014.

Treatment:

Drug: LY900014

Insulin Lispro (Humalog®)

Active Comparator group

Description:

T1DM participants received a single, individualized, SC dose of insulin lispro.

Treatment:

Drug: Insulin Lispro

Insulin Aspart (NovoRapid®)

Active Comparator group

Description:

T1DM participants received a single, individualized, SC dose of insulin aspart.

Treatment:

Drug: Insulin Aspart

Drug: Insulin Aspart

Insulin Aspart (Fiasp®)

Active Comparator group

Description:

T1DM participants received a single, individualized, SC dose of insulin aspart.

Treatment:

Drug: Insulin Aspart

Drug: Insulin Aspart

Healthy Participants

No Intervention group

Description:

Healthy participants who received no study drug.