A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-14

Study Completion Date

2017-01-04

Brief Summary

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The study will aim to evaluate the following:

* Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100.
* How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.
* How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016 U-100.

The study will last up to 17 weeks for each participant, including initial screening and follow up.

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Detailed Description

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Conditions

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Healthy

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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LY2963016 U-200 Formulation (Test)

LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods.

Group Type EXPERIMENTAL

LY2963016

Intervention Type DRUG

Administered SC

LY2963016 U-100 Formulation (Reference)

LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods.

Group Type EXPERIMENTAL

LY2963016

Intervention Type DRUG

Administered SC

Interventions

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LY2963016

Administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have a body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m²)
* Have a fasting plasma glucose less than (\<) 6.0 millimoles per liter (mmol/L) (108 milligram per deciliter \[mg/dL\])
* Have venous access sufficient to allow for blood sampling and clamp procedures per protocol

Exclusion Criteria

* Have known allergies to the study drug, or any components of the formulation
* Have donated or had a blood loss of 450 milliliter (mL) within 3 months prior to study enrollment

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes