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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995656
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 20, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date July 15, 2014
Study Start Date  ICMJE December 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes
Official Title  ICMJE Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY3108743 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Placebo - Capsule
    Administered orally
  • Drug: LY3108743 - Capsule
    Administered orally
  • Drug: Placebo - Solution
    Administered orally
  • Drug: LY3108743 - Solution
    Administered orally
Study Arms  ICMJE
  • Placebo Comparator: Placebo - Healthy
    Part A. Healthy participants will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
    Intervention: Drug: Placebo - Capsule
  • Experimental: LY3108743 - Healthy
    Part A. Healthy participants will receive a single oral dose of LY3108743 in dose escalation cohorts in up to 2 of 3 study periods.
    Intervention: Drug: LY3108743 - Capsule
  • Placebo Comparator: Placebo - Diabetes
    Part B. Participants with diabetes mellitus will receive a single oral dose of placebo matching LY3108732 in at least 1 of 3 study periods.
    Intervention: Drug: Placebo - Capsule
  • Experimental: LY3108743 - Diabetes
    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.
    Intervention: Drug: LY3108743 - Capsule
  • Placebo Comparator: 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.
    Intervention: Drug: Placebo - Solution
  • Experimental: 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.
    Intervention: Drug: LY3108743 - Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 20, 2013)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01995656
Other Study ID Numbers  ICMJE 15197
I7D-FW-SGAA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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
PRS Account Eli Lilly and Company
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP