Clinical trial NCT01995656: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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* Have previously completed or withdrawn from this study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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Pre-dose up to Day 6 (5 days post-dose)
Secondary outcomes:
measure: Maximum Change from Baseline up to 24 Hours in Level of Blood Glucose Before and After a Standard Meal
timeFrame: Baseline up to 24 hours
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY3108743
timeFrame: Baseline up to 48 hours
measure: Pharmacokinetics: Area Under the Curve (AUC) of LY3108743
timeFrame: Baseline up to 48 hours
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: