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

NCT01995656 | Completed Phase 1

• 2 other identifiers: 15197I7D-FW-SGAA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (6)

Placebo - Healthy

PLACEBO COMPARATOR

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

Drug: Placebo - Capsule

LY3108743 - Healthy

EXPERIMENTAL

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

Drug: LY3108743 - Capsule

Placebo - Diabetes

PLACEBO COMPARATOR

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

Drug: Placebo - Capsule

LY3108743 - Diabetes

EXPERIMENTAL

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.

Drug: LY3108743 - Capsule

Placebo - Solution

PLACEBO COMPARATOR

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.

Drug: Placebo - Solution

LY3108743 - Solution

EXPERIMENTAL

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.

Drug: LY3108743 - Solution

Interventions

Placebo - Capsule DRUG

Administered orally

Placebo - Diabetes; Placebo - Healthy

LY3108743 - Capsule DRUG

Administered orally

LY3108743 - Diabetes; LY3108743 - Healthy

Placebo - Solution DRUG

Administered orally

Placebo - Solution

LY3108743 - Solution DRUG

Administered orally

LY3108743 - Solution

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 117597, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: November 26, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-07

Locations

SG (1)