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

Phase 1CompletedNCT01995656

Eli Lilly and Company44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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A1c (HbA1c) level between 6 to 11%, inclusive, at screening Exclusion Criteria: * Have previously completed or withdrawn from this study * Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could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

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, Singapore

Outcomes

Primary Outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame: Pre-dose up to Day 6 (5 days post-dose)

Secondary Outcomes

Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal

Time frame: Baseline up to 24 hours

Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743

Time frame: Baseline up to 48 hours

Pharmacokinetics: Area Under the Curve (AUC) of LY3108743

Time frame: Baseline up to 48 hours