A Study of LY900014 in Elderly and Younger Adult 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

2017-05-24

Study Completion Date

2017-11-18

Brief Summary

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The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

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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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Elderly Adults LY900014

Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

Elderly Adults Insulin Lispro

Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC

Younger Adults LY900014

Single, SC 15-U dose of LY900014 in the younger adult group.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

Younger Adults Insulin Lispro

Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC

Interventions

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LY900014

Administered SC

Intervention Type DRUG

Insulin Lispro

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro Humalog LY275585

Eligibility Criteria

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Inclusion Criteria

* Are male or female participants with Type 1 Diabetes Mellitus (T1DM)
* Have a body mass index (BMI) of 18.5 to 30.0 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
* Have a history of renal impairment
* Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
* Have proliferative retinopathy or maculopathy and/or severe neuropathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No