Back to resultsA Study of LY3325656 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
LY3325656
Placebo
Liraglutide
Sitagliptin
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
For all participants:
- 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 screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
- Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
For participants with Type 2 Diabetes Mellitus:
- Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
- Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
- Have a HbA1c value of greater than or equal to 7% and less than or equal to 8.5% at screening (sulfonylureas with or without metformin)
Exclusion Criteria:
For all participants:
- Are currently participating in another clinical study or completed one in the last 30 days
- Are allergic to LY3325656 or other related drugs
- Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
- Have electrocardiogram (ECG) readings that are not suitable for the study
- Are infected with hepatitis B
- Are infected with human immunodeficiency virus (HIV)
- Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
- Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
For participants with Type 2 Diabetes Mellitus:
- Have had heart disease or stroke within 6 months before entering the study
- Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
- Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
- Have used insulin to control diabetes in the last 6 months
- Show symptoms of high blood sugar e.g. frequent urination, always feeling thirsty, or unexpected weight loss
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 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
Active Comparator
Experimental
Arm Label
Placebo (Part A)
LY3325656 (Part A)
Placebo (Part B)
LY3325656 (Part B)
Liraglutide (Part B)
LY3325656 + Sitagliptin (Part B)
Arm Description
Single oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A
Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A
Single oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B
Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B
Single subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B
Single oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656
Pharmacokinetics: Area Under the Concentration Curve of LY3325656 From Time Zero to 24 Hours [AUC(0-24)]
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03115099
Brief Title
A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes
Official Title
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3325656 After Single Dose in Healthy Subjects and Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 31, 2017 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
April 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected.
It will also investigate how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it.
The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.
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
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
Single oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A
Arm Title
LY3325656 (Part A)
Arm Type
Experimental
Arm Description
Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Single oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B
Arm Title
LY3325656 (Part B)
Arm Type
Experimental
Arm Description
Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B
Arm Title
Liraglutide (Part B)
Arm Type
Active Comparator
Arm Description
Single subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B
Arm Title
LY3325656 + Sitagliptin (Part B)
Arm Type
Experimental
Arm Description
Single oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B
Intervention Type
Drug
Intervention Name(s)
LY3325656
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
Administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
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
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656
Description
Pharmacokinetics: Area Under the Concentration Curve of LY3325656 From Time Zero to 24 Hours [AUC(0-24)]
Time Frame
Baseline up to 72 hours after each dose of study drug
Title
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Description
Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656
Time Frame
Baseline up to 72 hours after each dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For all participants:
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 screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
For participants with Type 2 Diabetes Mellitus:
Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
Have a HbA1c value of greater than or equal to 7% and less than or equal to 8.5% at screening (sulfonylureas with or without metformin)
Exclusion Criteria:
For all participants:
Are currently participating in another clinical study or completed one in the last 30 days
Are allergic to LY3325656 or other related drugs
Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
Have electrocardiogram (ECG) readings that are not suitable for the study
Are infected with hepatitis B
Are infected with human immunodeficiency virus (HIV)
Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
For participants with Type 2 Diabetes Mellitus:
Have had heart disease or stroke within 6 months before entering the study
Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
Have used insulin to control diabetes in the last 6 months
Show symptoms of high blood sugar e.g. frequent urination, always feeling thirsty, or unexpected weight loss
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 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
City
Singapore
ZIP/Postal Code
117597
Country
Singapore
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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Learn more about this trial
A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes
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