A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes

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

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-04-30

Brief Summary

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The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3108743 in healthy participants and in participants with type 2 diabetes.

The study will also investigate how LY3108743 affects the levels of blood sugar and other naturally occurring substances (e.g. hormones that control the way sugar is used) in the body, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.

Information about any side effects that may occur will be collected. The study is expected to last approximately 7 to 8 weeks for each participant.

The study will have up to 3 parts. Participants may enroll in only one part.

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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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Placebo - Healthy

Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.

Group Type PLACEBO_COMPARATOR

Placebo - Capsule

Intervention Type DRUG

Administered orally

LY3108743 - Healthy

Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.

Group Type EXPERIMENTAL

LY3108743 - Capsule

Intervention Type DRUG

Administered orally

Placebo - Diabetes

Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.

Group Type PLACEBO_COMPARATOR

Placebo - Capsule

Intervention Type DRUG

Administered orally

LY3108743 - Diabetes

Part B. Participants with diabetes mellitus will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.

Group Type EXPERIMENTAL

LY3108743 - Capsule

Intervention Type DRUG

Administered orally

Placebo - Solution

Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of placebo matching LY3108743 in 1 of 2 study periods.

Group Type PLACEBO_COMPARATOR

Placebo - Solution

Intervention Type DRUG

Administered orally

LY3108743 - Solution

Part C. Contingent on results from Parts A and B. Healthy participants will receive a single oral dose of LY3108743 in 1 of 2 study periods.

Group Type EXPERIMENTAL

LY3108743 - Solution

Intervention Type DRUG

Administered orally

Interventions

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Placebo - Capsule

Administered orally

Intervention Type DRUG

LY3108743 - Capsule

Administered orally

Intervention Type DRUG

Placebo - Solution

Administered orally

Intervention Type DRUG

LY3108743 - Solution

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
* Have a body mass index (BMI) of 18.5 to 40.0 kilogram per square meter (kg/m\^2), inclusive, at screening
* Have normal blood pressure
* Participants with diabetes must not be taking any anti-hyperglycemic medications with the exception of metformin. If on metformin, participants must be on a stable treatment regimen for at least for 4 weeks prior to screening
* Participants with diabetes must have a hemoglobin A1c (HbA1c) level between 6 to 11%, inclusive, at screening

Exclusion Criteria

* Have previously completed or withdrawn from this study
* Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes