A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2018-03-31

Brief Summary

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The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.

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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 Before Meal

Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.

Group Type EXPERIMENTAL

LY900014

Intervention Type BIOLOGICAL

Administered SC

LY900014 After Meal

Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.

Group Type EXPERIMENTAL

LY900014

Intervention Type BIOLOGICAL

Administered SC

Insulin Lispro (Humalog) Before Meal

Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type BIOLOGICAL

Administered SC

Insulin Lispro (Humalog) After Meal

Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type BIOLOGICAL

Administered SC

Interventions

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LY900014

Administered SC

Intervention Type BIOLOGICAL

Insulin Lispro

Administered SC

Intervention Type BIOLOGICAL

Other Intervention Names

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Ultra-Rapid Lispro LY275585 Humalog

Eligibility Criteria

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Inclusion Criteria

* Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
* Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
* Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
* Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening

Exclusion Criteria

* Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
* Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening
* Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
* Are treated with a CSII (insulin pump)
* Require daily insulin treatment greater than (\>)1.2 units per kilogram per body weight (U/kg/body weight)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No