A Study of LY900014 in Participants With Type 2 Diabetes Mellitus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-11

Study Completion Date

2017-12-14

Brief Summary

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The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

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 and 8 weeks.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

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

Single, subcutaneous (SC) dose of 15 Units (U) LY900014 in one of two study periods

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

Insulin Lispro (Humalog)

Single SC dose of 15 U insulin lispro (Humalog) in one of two study periods

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 LY275585 Humalog

Eligibility Criteria

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Inclusion Criteria

* Are male or female participants with Type 2 Diabetes Mellitus (T2DM) 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 T2DM), 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

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No