Diabetes Mellitus, Type 2
Conditions
Keywords
Metabolic Diseases, Glucose Metabolism Disorders, Diabetes, GLP-1, Lilly
Brief summary
The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.
Interventions
DRUGLY2189265
Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
DRUGPlacebo
Administered by SC injection, QW for 12 weeks.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m\^2) but \<40.0 kg/m\^2. * Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD. * Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%. * Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.
Exclusion criteria
* Patients who are currently taking prescription medications to promote weight loss * Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening. * Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility. * Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension. * Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range. * Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks | Baseline, 12 weeks | Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks | up to 12 weeks | Percentage of participants achieving HbA1c\<6.5% up to the 12-week endpoint. |
| Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks | Baseline, 12 weeks | Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect. |
| Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks | Baseline, 12 weeks | SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose\*visit, where the participant was treated as a random effect. |
| Change From Baseline in Total Body Weight at 12 Weeks | Baseline, 12 weeks | Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect. |
| Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks | up to 12 weeks | Percentage of participants who achieved HbA1c\<7% up to the 12-week endpoint. |
| Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks | Baseline, 12 weeks | HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect. |
| Steady-State Concentrations of LY2189265 | 12 weeks | Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®. |
| Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period | 12 weeks | Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L). |
| Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks | Baseline, 12 weeks | HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.75 mg LY2189265 Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks. | 35 |
| 0.5 mg LY2189265 Administered by SC injection, QW for 12 weeks. | 37 |
| 0.25 mg LY2189265 Administered by SC injection, QW for 12 weeks. | 36 |
| Placebo Administered by SC injection, QW for 12 weeks. | 37 |
| Total | 145 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 0 |
| Overall Study | Entry Criteria Not Met | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | 0.75 mg LY2189265 | 0.5 mg LY2189265 | 0.25 mg LY2189265 |
|---|---|---|---|---|---|
| Age, Continuous | 51.70 years STANDARD_DEVIATION 9.67 | 52.17 years STANDARD_DEVIATION 8.82 | 52.23 years STANDARD_DEVIATION 7.8 | 52.50 years STANDARD_DEVIATION 9.17 | 52.26 years STANDARD_DEVIATION 8.82 |
| Fasting Blood Glucose (FBG) | 159.65 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 33.29 | 156.45 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 31.26 | 156.51 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 26.43 | 150.95 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 29.31 | 158.75 milligrams per deciliter (mg/dL) STANDARD_DEVIATION 35.62 |
| Percentage of Glycosylated Hemoglobin (HbA1c) | 7.98 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.64 | 8.00 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.64 | 8.01 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.63 | 7.98 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.66 | 8.05 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.66 |
| Race/Ethnicity, Customized Japanese | 37 participants | 145 participants | 35 participants | 37 participants | 36 participants |
| Region of Enrollment Japan | 37 participants | 145 participants | 35 participants | 37 participants | 36 participants |
| Sex: Female, Male Female | 8 Participants | 38 Participants | 7 Participants | 14 Participants | 9 Participants |
| Sex: Female, Male Male | 29 Participants | 107 Participants | 28 Participants | 23 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 16 / 37 | 17 / 36 | 18 / 37 | 15 / 35 |
| serious Total, serious adverse events | 0 / 37 | 1 / 36 | 0 / 37 | 1 / 35 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks
Change in HbA1c from baseline following 12 weeks of therapy (that is, HbA1c at week 12 minus HbA1c at baseline). Changes in HbA1c were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.
Time frame: Baseline, 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.75 mg LY2189265 | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -1.35 percentage glycosylated hemoglobin |
| 0.5 mg LY2189265 | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -1.15 percentage glycosylated hemoglobin |
| 0.25 mg LY2189265 | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -0.90 percentage glycosylated hemoglobin |
| Placebo | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -0.18 percentage glycosylated hemoglobin |
p-value: <0.001Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
Secondary
Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks
HOMA2-B is an estimated steady state beta cell function based on updated HOMA2 model. The HOMA2 model estimates steady state pancreatic beta cell function (%B) as a percentage of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-B were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.
Time frame: Baseline, 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.75 mg LY2189265 | Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks | 38.63 percentage beta-cell function |
| 0.5 mg LY2189265 | Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks | 26.67 percentage beta-cell function |
| 0.25 mg LY2189265 | Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks | 20.04 percentage beta-cell function |
| Placebo | Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks | 6.94 percentage beta-cell function |
p-value: <0.001Mixed Models Analysis
p-value: 0.036Mixed Models Analysis
p-value: 0.002Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
Secondary
Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks
Change in FBG following 12 weeks of therapy (that is, FBG at week 12 minus FBG at baseline). The change in FBG was analyzed using a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.
Time frame: Baseline, 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.75 mg LY2189265 | Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks | -37.48 milligrams per deciliter (mg/dL) |
| 0.5 mg LY2189265 | Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks | -28.55 milligrams per deciliter (mg/dL) |
| 0.25 mg LY2189265 | Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks | -29.21 milligrams per deciliter (mg/dL) |
| Placebo | Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks | -9.00 milligrams per deciliter (mg/dL) |
p-value: <0.001Mixed Models Analysis
p-value: 0.003Mixed Models Analysis
p-value: 0.003Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
Secondary
Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks
HOMA2-S is an estimated insulin sensitivity based on updated HOMA2 model. The HOMA2 model is a computer model that estimates insulin sensitivity (%S) as percentages of a normal reference population using simultaneously measured fasting plasma glucose and fasting insulin. Changes in HOMA2-S were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.
Time frame: Baseline, 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.75 mg LY2189265 | Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks | -4.66 percentage insulin sensitivity (%S) |
| 0.5 mg LY2189265 | Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks | -6.07 percentage insulin sensitivity (%S) |
| 0.25 mg LY2189265 | Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks | 4.65 percentage insulin sensitivity (%S) |
| Placebo | Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks | 3.74 percentage insulin sensitivity (%S) |
p-value: 0.202Mixed Models Analysis
p-value: 0.917Mixed Models Analysis
p-value: 0.264Mixed Models Analysis
p-value: 0.346Mixed Models Analysis
Secondary
Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks
SMBG levels were measured at the following 7 timepoints during the day: fasting prebreakfast, 2 hours postbreakfast, prior to lunch, 2 hours postlunch, prior to dinner, 2 hours postdinner, and prior to bed. The change in mean daily blood glucose was analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, and dose\*visit, where the participant was treated as a random effect.
Time frame: Baseline, 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.75 mg LY2189265 | Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks | -48.99 milligrams per deciliter (mg/dL) |
| 0.5 mg LY2189265 | Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks | -53.12 milligrams per deciliter (mg/dL) |
| 0.25 mg LY2189265 | Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks | -40.70 milligrams per deciliter (mg/dL) |
| Placebo | Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks | -7.49 milligrams per deciliter (mg/dL) |
p-value: <0.001Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
p-value: <0.001Mixed Models Analysis
Secondary
Change From Baseline in Total Body Weight at 12 Weeks
Changes in body weight were analyzed by a mixed model repeated measures (MMRM) model that included dose, pre-study therapy, body mass index (BMI) group at baseline, baseline value, visit, and dose\*visit, where the participant was treated as a random effect.
Time frame: Baseline, 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| 0.75 mg LY2189265 | Change From Baseline in Total Body Weight at 12 Weeks | -0.58 kilograms (kg) |
| 0.5 mg LY2189265 | Change From Baseline in Total Body Weight at 12 Weeks | -0.40 kilograms (kg) |
| 0.25 mg LY2189265 | Change From Baseline in Total Body Weight at 12 Weeks | 0.41 kilograms (kg) |
| Placebo | Change From Baseline in Total Body Weight at 12 Weeks | -0.84 kilograms (kg) |
p-value: 0.987Mixed Models Analysis
p-value: 0.005Mixed Models Analysis
p-value: 0.311Mixed Models Analysis
p-value: 0.556Mixed Models Analysis
Secondary
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks
Percentage of participants achieving HbA1c\<6.5% up to the 12-week endpoint.
Time frame: up to 12 weeks
Population: All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.75 mg LY2189265 | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks | 34.3 percentage of participants |
| 0.5 mg LY2189265 | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks | 24.3 percentage of participants |
| 0.25 mg LY2189265 | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks | 8.3 percentage of participants |
| Placebo | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks | 2.7 percentage of participants |
p-value: <0.001Cochran-Armitage
p-value: 0.358Fisher Exact
p-value: 0.014Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks
Percentage of participants who achieved HbA1c\<7% up to the 12-week endpoint.
Time frame: up to 12 weeks
Population: All randomized participants who received at least 1 dose of the study drug, last observation carried forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.75 mg LY2189265 | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks | 77.1 percentage of participants |
| 0.5 mg LY2189265 | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks | 59.5 percentage of participants |
| 0.25 mg LY2189265 | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks | 47.2 percentage of participants |
| Placebo | Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks | 10.8 percentage of participants |
p-value: <0.001Cochran-Armitage
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
p-value: <0.001Fisher Exact
Secondary
Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period
Assessed the percentage of participants who reported a hypoglycemic episode during the 12-week treatment period. Hypoglycemia was defined as a measured plasma glucose level of ≤70 milligrams per deciliter (mg/dL) or ≤3.9 millimoles per liter (mmol/L).
Time frame: 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0.75 mg LY2189265 | Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period | 5.7 percentage of participants |
| 0.5 mg LY2189265 | Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period | 2.7 percentage of participants |
| 0.25 mg LY2189265 | Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period | 0.0 percentage of participants |
p-value: 0.073Cochran-Armitage
p-value: 1Fisher Exact
p-value: 0.233Fisher Exact
Secondary
Steady-State Concentrations of LY2189265
Evaluable pharmacokinetics (PK) concentrations from all sampling time-points were combined and utilized in a population approach to determine the population mean estimate and standard deviation at 12 weeks. The model predicted LY2189265 steady state concentrations in each dose level were calculated as estimated area under the curve (AUC)/dosing period of 168 hours. The models and model parameters were described by nonlinear, mixed-effects regression modeling (NONMEM) using the program NONMEM 7®.
Time frame: 12 weeks
Population: Full analysis set: All randomized participants who received at least 1 dose of the study drug.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 0.75 mg LY2189265 | Steady-State Concentrations of LY2189265 | 15.8 nanograms per milliliter (ng/mL) |
| 0.5 mg LY2189265 | Steady-State Concentrations of LY2189265 | 28.8 nanograms per milliliter (ng/mL) |
| 0.25 mg LY2189265 | Steady-State Concentrations of LY2189265 | 42.7 nanograms per milliliter (ng/mL) |