Type 2 Diabetes
Conditions
Keywords
Diabetes, Type 2 Diabetes
Brief summary
Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.
Interventions
DRUGLY2189102
Participants received 2 subcutaneous (SC) injections weekly for 12 weeks.
DRUGPlacebo
Participants received 2 SC injections weekly 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
* Have Type 2 Diabetes and confirmed by fasting C-peptide levels greater than or equal to 0.8 nanograms per milliliter \[ng/ml\]), with duration of more than 3 months. * Body mass index between 25 and 40 kilograms per square meter (kg/m2). * Stable on diet and exercise alone, with or without metformin monotherapy (stable regimen or dose for at least 8 weeks). * Drug-naïve or previous anti-diabetic pharmacotherapy use is allowed (for the latter, patient must have stopped taking pharmacotherapy greater than 12 weeks prior to screening and only if deemed appropriate by the investigator). * Angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, thiazide diuretics or calcium channel blockers are permitted for the treatment of hypertension or proteinuria. * Glycated hemoglobin level between 7% and 10%. * Baseline High-sensitivity C-reactive protein greater than or equal to 2 milligrams per liter (mg/L) * Females of childbearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must test negative for pregnancy at the time of enrollment based on a pregnancy test. Furthermore, sexually active female and male participants must agree to use 2 reliable methods of birth control during the study and for 3 months following the last dose of study drug. * Reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
Exclusion criteria
* Current use of anti-diabetic pharmacotherapy (except metformin, under conditions specified in Inclusion Criteria above). * Current treatment with anti-inflammatory drugs, including corticosteroids and non-steroidal anti-inflammatory drugs (100 mg per day or less of aspirin allowed). * Within 60 days of the initial dose of the study drug, have received treatment with a drug that has not received regulatory approval for any indication. * Presence of autoantibodies to glutamic acid decarboxylase 65 or islet-cell autoantibody-2. * Evidence of tuberculosis as documented by a specific assay, medical history, and chest x-ray. A specific assay, (for example, tuberculin testing) will be conducted unless it is medically inappropriate. Exceptions include patients with a history of a positive specific assay for TB who have been treated with isonicotinyl hydrazine (documented) for at least 6 months, or patients with a previous diagnosis of TB who have been appropriately treated and can provide documentation. * Symptomatic herpes zoster within 3 months of randomization. * Show evidence of hepatitis C and/or positive hepatitis B surface antigen. * Show evidence of human immunodeficiency virus and/or positive test of antibodies to human immunodeficiency virus (HIV). * Received live or attenuated vaccine(s) within the previous 3 months prior to randomization or will receive within 3 months from the end of study. * Screening serum creatinine greater than 2.0 milligrams per deciliter (mg/dL). * Serum aspartate aminotransferase or alanine aminotransaminase concentration greater than 2x the upper limit of normal. * Known allergies to LY2189102 or excipients. * Previously completed or withdrawn from this study or any other study investigating LY2189102. * Have donated blood of greater than 500 mL within the preceding 30 days and intend to donate within 3 months from the end of study. * Have had other recent or ongoing signs of infection (for example, fever, current treatment with antibiotics). * Experienced a serious bacterial infection within 6 months of randomization. * Have a serious medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, or neurological disease, or any clinically significant laboratory abnormality. * Have had lymphoma, leukemia, or any non-breast malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease. * Have had a previous reaction to other biologics that, in the opinion of the investigator, puts the patient at serious risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the 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). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks | Baseline, 12 weeks | Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. |
| Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Baseline, 12 weeks | The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT. |
| Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | Baseline, week 10, week 12 | The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. |
| Change From Baseline in Fasting Glucose at 12 Weeks | Baseline, 12 weeks | Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate. |
| PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks) | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose | Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model. |
| Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks) | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose | Pharmacokinetics Measured by Serum Concentration at End of Dosing. |
| Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks) | Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose | The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.6 mg LY2189102 Participants received 2 subcutaneous (SC) injections weekly for 12 weeks. | 26 |
| 18 mg LY2189102 Participants received 2 SC injections weekly for 12 weeks. | 26 |
| 180 mg LY2189102 Participants received 2 SC injections weekly for 12 weeks. | 27 |
| Placebo Participants received 2 SC injections of 0.9% sodium chloride weekly for 12 weeks. | 27 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 2 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 1 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 0 | 0 |
| Overall Study | Sponsor Decision | 0 | 2 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 4 | 2 |
Baseline characteristics
| Characteristic | Total | 0.6 mg LY2189102 | 18 mg LY2189102 | 180 mg LY2189102 | Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 52.7 years STANDARD_DEVIATION 9.05 | 52.9 years STANDARD_DEVIATION 6.75 | 53.7 years STANDARD_DEVIATION 10.74 | 51.3 years STANDARD_DEVIATION 9.17 | 52.9 years STANDARD_DEVIATION 9.41 |
| Body Mass Index (BMI) | 33.1 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.01 | 33.0 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.73 | 33.7 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.72 | 33.1 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.02 | 32.5 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.62 |
| Fasting Glucose | 9.208 millimoles per liter (mmol/L) STANDARD_DEVIATION 2.0688 | 8.152 millimoles per liter (mmol/L) STANDARD_DEVIATION 1.8154 | 9.106 millimoles per liter (mmol/L) STANDARD_DEVIATION 2.2001 | 10.300 millimoles per liter (mmol/L) STANDARD_DEVIATION 2.144 | 9.339 millimoles per liter (mmol/L) STANDARD_DEVIATION 1.7315 |
| Fasting Insulin | 14.821 microinternational units per milliliter STANDARD_DEVIATION 11.7856 | 15.083 microinternational units per milliliter STANDARD_DEVIATION 12.0562 | 15.034 microinternational units per milliliter STANDARD_DEVIATION 6.9383 | 13.989 microinternational units per milliliter STANDARD_DEVIATION 14.4076 | 15.120 microinternational units per milliliter STANDARD_DEVIATION 12.5253 |
| High-sensitivity C-reactive Protein (hsCRP) | 6.373 milligrams per liter (mg/L) STANDARD_DEVIATION 5.5685 | 6.214 milligrams per liter (mg/L) STANDARD_DEVIATION 6.2179 | 6.024 milligrams per liter (mg/L) STANDARD_DEVIATION 4.4956 | 7.183 milligrams per liter (mg/L) STANDARD_DEVIATION 6.9691 | 6.093 milligrams per liter (mg/L) STANDARD_DEVIATION 4.5289 |
| Number of Participants on Anti-diabetic Medications Biguanides | 85 Participants | 20 Participants | 23 Participants | 22 Participants | 20 Participants |
| Number of Participants on Anti-diabetic Medications DPP-4 Inhibitors | 4 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants |
| Number of Participants on Anti-diabetic Medications Enhancers of Insulin Effects | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Number of Participants on Anti-diabetic Medications Glucagon-like Peptide (GLP) Analogs and Agonists | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Number of Participants on Anti-diabetic Medications Sufonylureas | 26 Participants | 8 Participants | 7 Participants | 5 Participants | 6 Participants |
| Number of Participants on Diet and Exercise Only Diet and Exercise Only - No | 87 Participants | 21 Participants | 23 Participants | 23 Participants | 20 Participants |
| Number of Participants on Diet and Exercise Only Diet and Exercise Only - Yes | 19 Participants | 5 Participants | 3 Participants | 4 Participants | 7 Participants |
| Percentage of Glycosylated Fraction of Hemoglobin (HbA1c) | 7.882 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.7544 | 7.540 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.5596 | 7.950 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.7002 | 8.271 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.938 | 7.824 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.6557 |
| Race/Ethnicity, Customized African | 15 Participants | 3 Participants | 6 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 38 Participants | 6 Participants | 12 Participants | 10 Participants | 10 Participants |
| Race/Ethnicity, Customized East Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 49 Participants | 15 Participants | 7 Participants | 13 Participants | 14 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 106 Participants | 26 Participants | 26 Participants | 27 Participants | 27 Participants |
| Sex: Female, Male Female | 67 Participants | 15 Participants | 17 Participants | 15 Participants | 20 Participants |
| Sex: Female, Male Male | 39 Participants | 11 Participants | 9 Participants | 12 Participants | 7 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 | 19 / 26 | 19 / 26 | 23 / 27 | 20 / 27 |
| serious Total, serious adverse events | 1 / 26 | 1 / 26 | 0 / 27 | 0 / 27 |
Outcome results
Primary
Change From Baseline in the 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). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline HbA1c as a continuous covariate.
Time frame: Baseline, 12 weeks
Population: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.6 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -0.457 percentage of glycosylated hemoglobin | Standard Error 0.1454 |
| 18 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -0.561 percentage of glycosylated hemoglobin | Standard Error 0.153 |
| 180 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -0.428 percentage of glycosylated hemoglobin | Standard Error 0.1379 |
| Placebo | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at 12 Weeks | -0.183 percentage of glycosylated hemoglobin | Standard Error 0.1315 |
Secondary
Change From Baseline in Fasting Glucose at 12 Weeks
Change in fasting glucose following 12 weeks of therapy (that is, fasting glucose at week 12 minus fasting glucose at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.
Time frame: Baseline, 12 weeks
Population: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.6 mg LY2189102 | Change From Baseline in Fasting Glucose at 12 Weeks | -0.873 millimole per liter (mmol/L) | Standard Error 0.4802 |
| 18 mg LY2189102 | Change From Baseline in Fasting Glucose at 12 Weeks | -1.270 millimole per liter (mmol/L) | Standard Error 0.5299 |
| 180 mg LY2189102 | Change From Baseline in Fasting Glucose at 12 Weeks | -0.629 millimole per liter (mmol/L) | Standard Error 0.4591 |
| Placebo | Change From Baseline in Fasting Glucose at 12 Weeks | -0.019 millimole per liter (mmol/L) | Standard Error 0.4404 |
95% CI: [-1.94, 0.23]ANCOVA
95% CI: [-2.48, -0.03]ANCOVA
95% CI: [-1.76, 0.54]ANCOVA
Secondary
Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks
Change in serum fasting insulin from baseline to endpoint (that is, serum insulin at week 12 minus serum insulin at week 0). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.
Time frame: Baseline, 12 weeks
Population: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 0.6 mg LY2189102 | Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks | -1.589 microinternational Units per liter | Standard Error 2.9549 |
| 18 mg LY2189102 | Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks | -0.918 microinternational Units per liter | Standard Error 3.3206 |
| 180 mg LY2189102 | Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks | -0.229 microinternational Units per liter | Standard Error 2.7836 |
| Placebo | Change From Baseline in Insulin Sensitivity (Fasting Insulin) at 12 Weeks | 1.405 microinternational Units per liter | Standard Error 2.8722 |
95% CI: [-9.82, 3.83]ANCOVA
95% CI: [-10.21, 5.56]ANCOVA
95% CI: [-9.16, 5.89]ANCOVA
Secondary
Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12
The change from baseline in HbA1c at week 10 (that is HbA1c at week 10 minus HbA1c at baseline) and week 12 (that is, HbA1c at week 12 minus HbA1c at baseline). The Least Squares (LS) Mean Value was based on an analysis of covariance (ANCOVA) model with treatment and site as class variables and baseline value as a continuous covariate.
Time frame: Baseline, week 10, week 12
Population: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 0.6 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 10 | -0.456 percentage glycosylated hemoglobin | Standard Error 0.1459 |
| 0.6 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 12 | -0.459 percentage glycosylated hemoglobin | Standard Error 0.156 |
| 18 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 12 | -0.588 percentage glycosylated hemoglobin | Standard Error 0.1712 |
| 18 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 10 | -0.555 percentage glycosylated hemoglobin | Standard Error 0.1541 |
| 180 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 12 | -0.413 percentage glycosylated hemoglobin | Standard Error 0.1455 |
| 180 mg LY2189102 | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 10 | -0.413 percentage glycosylated hemoglobin | Standard Error 0.1412 |
| Placebo | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 10 | -0.186 percentage glycosylated hemoglobin | Standard Error 0.1322 |
| Placebo | Change From Baseline in the Glycosylated Hemoglobin (HbA1c) at Week 10 and Week 12 | HbA1c at Week 12 | -0.192 percentage glycosylated hemoglobin | Standard Error 0.141 |
95% CI: [-0.59, 0.05]ANCOVA
95% CI: [-0.74, 0]ANCOVA
95% CI: [-0.59, 0.13]ANCOVA
95% CI: [-0.61, 0.08]ANCOVA
95% CI: [-0.79, 0]ANCOVA
95% CI: [-0.59, 0.15]ANCOVA
Secondary
Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks
The number of participants with a change from baseline in glucose and insulin at 2 hours after the MMTT was analyzed. The MMTT measures glucose and insulin before and after a standardized meal is eaten. Glucose and insulin levels were measured before the MMTT and 2 hours after the MMTT.
Time frame: Baseline, 12 weeks
Population: Full analysis set. All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.6 mg LY2189102 | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Glucose at 2 hours | 22 participants |
| 0.6 mg LY2189102 | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Insulin at 2 hours | 22 participants |
| 18 mg LY2189102 | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Insulin at 2 hours | 17 participants |
| 18 mg LY2189102 | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Glucose at 2 hours | 17 participants |
| 180 mg LY2189102 | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Glucose at 2 hours | 18 participants |
| 180 mg LY2189102 | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Insulin at 2 hours | 18 participants |
| Placebo | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Glucose at 2 hours | 24 participants |
| Placebo | Number of Participants With a Change From Baseline in Beta-Cell Function Measured by Glucose and Insulin Changes With the Mixed Meal Tolerance Test (MMTT) at 12 Weeks | Insulin at 2 hours | 24 participants |
Secondary
Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks)
Pharmacokinetics Measured by Serum Concentration at End of Dosing.
Time frame: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose
Population: All participants who received at least one dose of study drug and had evaluable PK data. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.6 mg LY2189102 | Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks) | 252.83 nanograms per milliliter (ng/mL) | Standard Deviation 83.28 |
| 18 mg LY2189102 | Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks) | 5532.00 nanograms per milliliter (ng/mL) | Standard Deviation 1991.28 |
| 180 mg LY2189102 | Pharmacokinetics Measured by Serum Concentration at End of Dosing (12 Weeks) | 35815.79 nanograms per milliliter (ng/mL) | Standard Deviation 15961.46 |
Secondary
Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks)
The Cmax value measures the maximum serum concentration and is estimated for LY2189102. The values were generated as individual estimates from a population pharmacokinetics (PK) model. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.
Time frame: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose
Population: Full Analysis Set: All randomized participants who received at least 1 dose of the study drug according to the treatment they were assigned and for whom the data are considered sufficient and interpretable. Differences in Ns are due to either dropouts and no post-baseline measure or something occurred to the sample (for example, not taken, broke).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.6 mg LY2189102 | Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks) | 269.39 nanograms per milliliter (ng/mL) | Standard Deviation 88.23 |
| 18 mg LY2189102 | Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks) | 6094.67 nanograms per milliliter (ng/mL) | Standard Deviation 2153 |
| 180 mg LY2189102 | Pharmacokinetics (PK) Maximum Serum Concentration (Cmax) of LY2189102 at End of Dosing (12 Weeks) | 39994.74 nanograms per milliliter (ng/mL) | Standard Deviation 17880.45 |
Secondary
PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks)
Individual estimates of AUCtau at end of dosing generated from a population pharmacokinetic (PK) model.
Time frame: Prior to and 1 and 3-4 days after the first dose, prior to every other dose, and 6 and 12 weeks after the last dose
Population: Compliant set. All randomized participants receiving at least 11 doses of study drug were analyzed according to the treatment subjects were assigned. Placebo samples were not assayed for serum concentration of LY2189102 because the participants in the placebo treatment arm did not receive LY2189102 study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0.6 mg LY2189102 | PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks) | 45777.78 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 14933.09 |
| 18 mg LY2189102 | PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks) | 986533.33 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 340965.83 |
| 180 mg LY2189102 | PK: Area Under the Concentration Time Curve for Dosing Interval (Tau) at Steady State (AUCτ,SS) at End of Dosing (12 Weeks) | 6555789.47 nanogram*hour per milliliter (ng*h/mL) | Standard Deviation 2934693.46 |