A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Drug: Placebo - CapsuleDrug: LY3108743 - CapsuleDrug: Placebo - SolutionDrug: LY3108743 - Solution
- Registration Number
- NCT01995656
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- Have previously completed or withdrawn from this study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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo - Healthy Placebo - Capsule Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. LY3108743 - Diabetes LY3108743 - Capsule 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. LY3108743 - Healthy LY3108743 - Capsule Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods. Placebo - Solution 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. Placebo - Diabetes Placebo - Capsule Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods. LY3108743 - Solution 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.
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Pre-dose up to Day 6 (5 days post-dose)
- Secondary Outcome Measures
Name Time Method Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal Baseline up to 24 hours Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743 Baseline up to 48 hours Pharmacokinetics: Area Under the Curve (AUC) of LY3108743 Baseline up to 48 hours
Trial Locations
- 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