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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2018-08-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY900014

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

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

Insulin Lispro (Humalog®)

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

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC

Insulin Aspart (NovoRapid®)

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

Group Type ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type DRUG

Administered SC

Insulin Aspart (Fiasp®)

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

Group Type ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type DRUG

Administered SC

Healthy Participants

Healthy participants who received no study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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LY900014

Administered SC

Intervention Type DRUG

Insulin Lispro

Administered SC

Intervention Type DRUG

Insulin Aspart

Administered SC

Intervention Type DRUG

Insulin Aspart

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro Humalog® LY275585 NovoRapid® Fiasp®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes