A Comparison of LY2963016 to a Basal Insulin After a Single Dose in Healthy Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-07-31

Brief Summary

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The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy subjects. The study is approximately 12 weeks.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LY2963016

A single 0.5-unit per kilogram (U/kg) dose of LY2963016 will be administered subcutaneously.

Group Type EXPERIMENTAL

LY2963016

Intervention Type DRUG

Administered subcutaneously

Lantus

A single 0.5-U/kg dose of Lantus will be administered subcutaneously.

Group Type ACTIVE_COMPARATOR

Lantus

Intervention Type DRUG

Administered subcutaneously

Interventions

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LY2963016

Administered subcutaneously

Intervention Type DRUG

Lantus

Administered subcutaneously

Intervention Type DRUG

Other Intervention Names

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Insulin Glargine

Eligibility Criteria

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Inclusion Criteria

* Are overtly healthy males or females
* Have a body mass index (BMI) between 18.5 and 29.9 kilogram per square meter (kg/m\^2)
* Are nonsmokers
* Have normal blood pressure and pulse rate
* Have an electrocardiogram (ECG) considered as within normal limits
* Have clinical laboratory test results within normal reference range

Exclusion Criteria

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device
* Have known allergies to insulin or its excipients
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
* Show evidence of significant active neuropsychiatric disease
* Have a history of first-degree relatives known to have diabetes mellitus
* Have a fasting venous blood glucose \>6.0 millimoles per liter (mmol/L)
* Intend to use over-the-counter or prescription medication
* Have donated or had a blood loss of 450 milliliters (mL) or more in the past 3 months
* Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes