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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Placebo - Capsule
LY3108743 - Capsule
Placebo - Solution
LY3108743 - Solution
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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  • Have previously completed or withdrawn from this study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

Sites / Locations

  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo - Healthy

LY3108743 - Healthy

Placebo - Diabetes

LY3108743 - Diabetes

Placebo - Solution

LY3108743 - Solution

Arm Description

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

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

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

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal
Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743
Pharmacokinetics: Area Under the Curve (AUC) of LY3108743

Full Information

First Posted
November 20, 2013
Last Updated
July 11, 2014
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01995656
Brief Title
A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY3108743 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo - Healthy
Arm Type
Placebo Comparator
Arm Description
Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
Arm Title
LY3108743 - Healthy
Arm Type
Experimental
Arm Description
Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.
Arm Title
Placebo - Diabetes
Arm Type
Placebo Comparator
Arm Description
Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
Arm Title
LY3108743 - Diabetes
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo - Solution
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
LY3108743 - Solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo - Capsule
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
LY3108743 - Capsule
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo - Solution
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
LY3108743 - Solution
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743
Time Frame
Baseline up to 48 hours
Title
Pharmacokinetics: Area Under the Curve (AUC) of LY3108743
Time Frame
Baseline up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Singapore
ZIP/Postal Code
117597
Country
Singapore

12. IPD Sharing Statement

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

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