| Outcome Measures: |
Primary: Change From Baseline to 6 Months in Hepatic Fat Fraction, The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months | Secondary: Change From Baseline to 6 Months in Alanine Aminotransferase Levels, Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months|Number of Participants With Hepatobiliary Adverse Events of Special Interest (AESI), Number of participants with ALT or AST greater than 3 times the upper limit of normal at a post-baseline visit. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section., Baseline, 6 months|Change From Baseline to 6 Months in Fasting Lipids Levels, Lipid values (cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months|Change From Baseline to 6 Months in Fasting Blood Glucagon, Glucagon values assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months|Change From Baseline to 6 Months in Body Weight, Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months|Change From Baseline to 6 Months in Hemoglobin A1c (HbA1c), HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, visit, baseline score, and treatment-by-visit., Baseline, 6 months|Change From Baseline to 6 Months in Fasting Plasma Glucose, Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months|Change From Baseline to 6 Months in Blood Pressure, Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured in triplicate throughout the study. At each visit, all available blood pressure measurements for a subject were averaged to provide the blood pressure for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months|Change From Baseline to 6 Months in Pulse Rate, Seated pulse rate was measured in triplicate throughout the study. At each visit, all available pulse measurements for a subject were averaged to provide the pulse for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (\<=8.0%, \>8.0%), visit, baseline score, and treatment-by-visit., Baseline, 6 months|Change From Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG), 7-point profile consists of pre-meal and 2-hour postprandial SMBG measurements for the morning, midday, and evening meals in 1 day and at 3 AM (nocturnal blood glucose measurement). Pre-meal measurements were taken before the subject began eating the meal. Participants recorded their glucose measurements in their study diaries., Baseline, 6 months|Population Pharmacokinetics: Apparent Clearance of LY2409021, Reported as a Population Estimate with % Standard Errors of Estimation (SEE), 5th-95th confidence interval., Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,|Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021, Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,|Rate of Hypoglycemic Events Adjusted Per 30 Days, Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration \<=70 mg/dL (\<=39 mmol/L),is presented. Rate: (30 days) is calculated as: (number of episodes during the time period divided by the number of days during the time period) multiplied by 30., Baseline through 6 months|Number of Participants With Hypoglycemic Events, Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration \<=70 mg/dL (\<=39 mmol/L), is presented. The number of subjects with an event are subjects who had at least one episode of documented symptomatic hypoglycemia during the time period., Baseline through 6 months
|
| Locations: |
John Muir Health Network - The Osteoporosis Center, Concord, California, 94520, United States|Valley Endocrine, Fresno, Fresno, California, 93720, United States|National Research Institute, Los Angeles, California, 90057, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|New Horizon Research Center, Miami, Florida, 33175, United States|Clinical Research of West Florida, Inc., Tampa, Florida, 33603, United States|University of Hawaii, Honolulu, Hawaii, 96813, United States|East West Medical Institute, Honolulu, Hawaii, 96814, United States|Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Midwest CRC, Crystal Lake, Illinois, 60012, United States|Iderc, P.L.C., Des Moines, Iowa, 50314, United States|Cotton O'Neil Clinic, Topeka, Kansas, 66606, United States|Centex Studies, Inc, Lake Charles, Louisiana, 70601, United States|Cosmopolitan International Diabetes Center, Columbia, Missouri, 65212, United States|Mercy Medical Research Institute, Springfield, Missouri, 65807, United States|Palm Research Center, Las Vegas, Nevada, 89148, United States|SHS Clinical Research Group, Toms River, New Jersey, 08753, United States|Office:Alwine,Lk, Downingtown, Pennsylvania, 19335, United States|University Diabetes and Endocrine Consultants, Chattanooga, Tennessee, 37411, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|Galenos Research, Dallas, Texas, 75251, United States|San Gabriel Clinical Research, Georgetown, Texas, 78626, United States|Oakwell Clinical Research, San Antonio, Texas, 78218, United States|Victorium Clinical Research, San Antonio, Texas, 78240, United States|Polyclinic, Seattle, Washington, 98104, United States|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., Athens, 11527, Greece|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., Thessaloniki, 54636, Greece|PRADNET, Inc. Centro Especializado de Nutricion y Bariatria, Hato Rey, 00917, Puerto Rico|American Telemedicine Center, San Juan, 00917-3104, Puerto Rico|GCM Medical Group PSC, San Juan, 909, Puerto Rico|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., Changhua, 500, Taiwan|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., Yong Kung City, 71004, Taiwan
|
