A Study of LY2922470 in Healthy Participants and Particip... | NCT01746017 | Trialant
NCT01746017
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 3, 2019Actual
Enrollment
26Actual
Phase
Phase 1
Conditions
Diabetes Mellitus, Type 2
Interventions
Placebo
LY2922470
Countries
Singapore
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01746017
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14796
Secondary IDs
ID
Type
Description
Link
I6K-FW-GLEA
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY2922470 in Healthy Participants and Participants With Diabetes
Official Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of LY2922470 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Feb 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2012
Primary Completion Date
Mar 2013Actual
Completion Date
Mar 2013Actual
First Submitted Date
Dec 6, 2012
First Submission Date that Met QC Criteria
Dec 6, 2012
First Posted Date
Dec 10, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2017
Results First Submitted that Met QC Criteria
Feb 15, 2019
Results First Posted Date
Jun 3, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 15, 2019
Last Update Posted Date
Jun 3, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The aim of this trial is to evaluate the safety of the study drug in healthy participant and participant with diabetes. It will investigate 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 also be collected.
The study consists of two parts. Part A will study healthy participants in up to 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 weeks.
Detailed Description
Not provided
Conditions Module
Conditions
Diabetes Mellitus, Type 2
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
26Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo (Part A)
Placebo Comparator
Single oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A
Drug: Placebo
LY2922470 (Part A)
Experimental
Single ascending dose of LY2922470 [starting at 1 milligram (mg)] administered orally to healthy participants in up to 3 of 4 study periods in Part A
Drug: LY2922470
Placebo (Part B)
Placebo Comparator
Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B
Drug: Placebo
LY2922470 (Part B)
Experimental
Single ascending dose of LY2922470 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A
Drug: LY2922470
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Administered orally as capsules
Placebo (Part A)
Placebo (Part B)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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, is located in the Reported Adverse Events module.
Baseline to study completion up to 33 days
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
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 18.0 kilograms per square meter (kg/m^2)
Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
For participants with Type 2 Diabetes Mellitus (T2DM):
Do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening.
Have a glycated hemoglobin (HbA1c) value of greater than or equal to 6% and less than or equal to 11% at screening
Exclusion Criteria:
For all participants:
Are currently participating in another clinical study or completed one in the last 30 days
Are allergic to LY2922470 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 milliliter (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 T2DM:
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 1 year
Show symptoms of high blood sugar, for example (e.g.), frequent urination, always feeling thirsty, or unexpected weight loss
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
21 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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
Locations
Facility
Status
City
State
ZIP
Country
Contacts
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
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
This is a 2-part dose escalation study: Part A in healthy participants and Part B in participants with type 2 diabetes mellitus (T2DM). Participants in Part A participated in up to 4 intervention periods and participants in Part B participated in up to 3 intervention periods. There was an at least 8 days washout interval between each dosing.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A Cohort 1 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
FG001
Part A Cohort 1 Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo;
FG002
Part A Cohort 1 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
FG003
Part A Cohort 1 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 90mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470;
FG004
Part A Cohort 2 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470;
FG005
Part A Cohort 2 Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo;
FG006
Part A Cohort 2 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
FG007
Part A Cohort 2 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
FG008
Part B Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470;
FG009
Part B Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo;
FG010
Part B Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470;
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0063 subjects
FG0072 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
Received at Least 1 Dose of Study Drug
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Period 2
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 3
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Period 4
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All enrolled participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A Cohort 1 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 10 milligrams (mg) LY2922470; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
BG001
Part A Cohort 1 Sequence 2
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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, is located in the Reported Adverse Events module.
All enrolled participants who received at least 1 dose of study drug. Participants were analyzed based on the treatment they received.
Posted
Count of Participants
Participants
No
Baseline to study completion up to 33 days
ID
Title
Description
OG000
Placebo (Part A)
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
OG001
1 mg (Part A)
Adverse Events Module
Frequency Threshold
5
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (Part A)
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Faeces discoloured
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
Yes
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C000620333
LY2922470
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
LY2922470
Drug
Administered orally as capsules
LY2922470 (Part A)
LY2922470 (Part B)
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]
Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]
LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose
Singapore
FG004
2 subjects
FG0052 subjects
FG0063 subjects
FG0072 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
2 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
2 subjects
FG0042 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0083 subjects
FG0093 subjects
FG0103 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
2 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjectsPart B occurred only for 3 periods.
FG0090 subjectsPart B occurred only for 3 periods.
FG0100 subjectsPart B occurred only for 3 periods.
COMPLETED
FG0002 subjects
FG0012 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0051 subjects
FG0062 subjects
FG0072 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: 90mg LY2922470; Period 4: Placebo;
BG002
Part A Cohort 1 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: Placebo; Period 3: 90mg LY2922470; Period 4: 540mg LY2922470;
BG003
Part A Cohort 1 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 1mg LY2922470; Period 2: 10mg LY2922470; Period 3: Placebo; Period 4: 540mg LY2922470;
BG004
Part A Cohort 2 Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: Placebo; Period 4: 1350mg LY2922470;
BG005
Part A Cohort 2 Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: Placebo;
BG006
Part A Cohort 2 Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 3mg LY2922470; Period 2: Placebo; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
BG007
Part A Cohort 2 Sequence 4
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 30mg LY2922470; Period 3: 270mg LY2922470; Period 4: 1350mg LY2922470;
BG008
Part B Sequence 1
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: Placebo; Period 2: 540mg LY2922470; Period 3: 1080mg LY2922470;
BG009
Part B Sequence 2
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: 540mg LY2922470; Period 3: Placebo;
BG010
Part B Sequence 3
Participants received either Placebo or LY2922470 capsules orally as per the below dosing sequence in each period.
Period 1: 270mg LY2922470; Period 2: Placebo; Period 3: 1080mg LY2922470;
BG011
Total
Total of all reporting groups
2
BG0012
BG0022
BG0032
BG0042
BG0052
BG0063
BG0072
BG0083
BG0093
BG0103
BG01126
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Between 18 and 65 years
BG0002
BG0012
BG0022
BG0032
BG004
>=65 years
BG0000
BG0010
BG0020
BG0030
BG004
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Male
BG0002
BG0012
BG0022
BG0032
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Not Hispanic or Latino
BG0002
BG0012
BG0022
BG0032
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
Asian
BG0002
BG0012
BG0022
BG0032
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0000
BG0010
BG0020
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Singapore
Title
Measurements
BG0002
BG0012
BG0022
BG0032
BG0042
BG0052
BG0063
BG0072
BG0083
BG0093
BG0103
BG01126
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG002
3 mg (Part A)
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG003
10 mg (Part A)
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG004
30 mg (Part A)
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG005
90 mg (Part A)
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG006
270 mg (Part A)
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG007
540 mg (Part A)
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG008
1350 mg (Part A)
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG009
Placebo (Part B)
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
OG010
270 mg (Part B)
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG011
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG012
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
Units
Counts
Participants
OG00015
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
OG0086
OG0099
OG0106
OG0116
OG0126
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG0120
Secondary
Pharmacokinetics: Area Under the Concentration Curve of LY2922470 From Time Zero to 24 Hours [AUC(0-24)]
All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate AUC(0-24). Participants were analyzed based on the treatment they received.
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG001
3 mg (Part A)
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG002
10 mg (Part A)
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG003
30 mg (Part A)
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG004
90 mg (Part A)
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG005
270 mg (Part A)
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG006
540 mg (Part A)
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG007
1350 mg (Part A)
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG008
270 mg (Part B)
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG009
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG010
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00052.1± 30
OG001194± 26
OG002658± 33
OG003
Secondary
Pharmacokinetics: Maximum Concentration (Cmax) of LY2922470
All enrolled participants who received at least 1 dose of study drug and had sufficient pharmacokinetics data to calculate Cmax. Participants were analyzed based on the treatment they received.
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG001
3 mg (Part A)
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG002
10 mg (Part A)
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG003
30 mg (Part A)
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG004
90 mg (Part A)
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG005
270 mg (Part A)
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG006
540 mg (Part A)
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG007
1350 mg (Part A)
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG008
270 mg (Part B)
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG009
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG010
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG00011.1± 15
OG00130.5± 33
OG002111± 37
OG003
Secondary
Change From Baseline in Blood Glucose Area Under the Effective Concentration Curve From Time Zero to 24 Hours [AUEC(0-24)]
Least Squares (LS) mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
All participants who received at least 1 dose of study drug with both baseline and 24 hours postdose glucose AUEC(0-24) values. Participants were analyzed based on the treatment they received.
Posted
Least Squares Mean
Standard Error
millimoles*hour/Liter (mmol*h/L)
Baseline (predose for Part A and Day -1 time-matched for Part B), 24 hours postdose
ID
Title
Description
OG000
Placebo (Part A)
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
OG001
1 mg (Part A)
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG002
3 mg (Part A)
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG003
10 mg (Part A)
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG004
30 mg (Part A)
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG005
90 mg (Part A)
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG006
270 mg (Part A)
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG007
540 mg (Part A)
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG008
1350 mg (Part A)
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG009
Placebo (Part B)
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
OG010
270 mg (Part B)
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG011
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG012
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
Units
Counts
Participants
OG00015
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.88± 1.52
OG00110.49± 3.64
OG0021.29± 3.67
OG003
Secondary
Change From Baseline in C-Peptide Area Under the Effective Concentration Curve From Time Zero to 6 Hours [AUEC(0-6)]
LS mean values were adjusted for baseline, treatment, period, treatment sequence, participant and error.
All participants who received at least 1 dose of study drug with both baseline and 6 hours postdose C-peptide AUEC(0-6) values. Participants were analyzed based on the treatment they received.
Posted
Least Squares Mean
Standard Error
picomoles*hour/Liter (pmol*h/L)
Baseline (predose for Part A and Day -1 time-matched for Part B), 6 hours postdose
ID
Title
Description
OG000
Placebo (Part A)
Single oral dose of placebo administered to healthy participants in 1 of 4 study periods.
OG001
1 mg (Part A)
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG002
3 mg (Part A)
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG003
10 mg (Part A)
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG004
30 mg (Part A)
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG005
90 mg (Part A)
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG006
270 mg (Part A)
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG007
540 mg (Part A)
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG008
1350 mg (Part A)
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
OG009
Placebo (Part B)
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
OG010
270 mg (Part B)
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG011
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
OG012
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
Units
Counts
Participants
OG00015
OG0016
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0007349.88± 871.01
OG0016314.08± 1257.47
OG0026270.86± 1262.57
OG003
0
15
4
15
EG001
1 mg (Part A)
Single oral dose of 1 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
1
6
EG002
3 mg (Part A)
Single oral dose of 3 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
1
6
EG003
10 mg (Part A)
Single oral dose of 10 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
2
6
EG004
30 mg (Part A)
Single oral dose of 30 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
3
6
EG005
90 mg (Part A)
Single oral dose of 90 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
3
6
EG006
270 mg (Part A)
Single oral dose of 270 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
3
6
EG007
540 mg (Part A)
Single oral dose of 540 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
1
6
EG008
1350 mg (Part A)
Single oral dose of 1350 mg LY2922470 administered to healthy participants in 1 of 4 study periods.
0
6
2
6
EG009
Placebo (Part B)
Single oral dose of placebo administered to participants with T2DM in 1 of 3 study periods.
0
9
3
9
EG010
270 mg (Part B)
Single oral dose of 270 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
0
6
3
6
EG011
540 mg (Part B)
Single oral dose of 540 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.
0
6
2
6
EG012
1080 mg (Part B)
Single oral dose of 1080 mg LY2922470 administered to participants with T2DM in 1 of 3 study periods.