A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2018-02-06

Brief Summary

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This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

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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 dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

Insulin Lispro (Humalog)

Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six 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

* Healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
* Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results
* Are nonsmokers, have not smoked for at least 6 months prior to entering the study

Exclusion Criteria

* Are currently participating in or completed a clinical trial within the last 30 days
* Have previously participated or withdrawn from this study
* Have donated blood or have blood loss of more than 500 mL within the past 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes