| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time., Baseline, Week 12 | Secondary: Change From Baseline in HbA1c at Week 24, HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time., Baseline, Week 24|Percent Change From Baseline in Body Weight, Baseline, Week 12; Baseline, Week 24|Change From Baseline in Fasting Blood Glucose, Least square means (LSM) was calculated from mixed-effects model with repeated measures (MMRM) analysis using restricted maximum likelihood (REML) with metformin use, baseline body mass index (BMI) category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect., Baseline, Week 12; Baseline, Week 24|Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values, SMBG 7-point profiles were measured at morning pre-meal, morning 2 hours post-meal, mid-day pre-meal, mid-day 2 hours post-meal, evening pre-meal, evening 2 hours post-meal, and at bedtime. LSM were calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect., Baseline, Week (Wk) 12; Baseline, Week 24|Change From Baseline in Lipids, Change from baseline in high-density lipoprotein cholesterol (HDL-C), total cholesterol, triglycerides, and low-density lipoprotein cholesterol (LDL-C). LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant an a random effect., Baseline, Week 24|Change From Baseline in Fasting Fibroblast Growth Factor 21, LSM was calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect., Baseline, Week 12; Baseline, Week 24|Percentage of Participants Requiring Rescue Therapy, Participants who received rescue medication with non-study antihyperglycemic medications or change their stable dose of metformin., Baseline through Therapy Completion (Week 24)|Percentage of Participants Developing Anti-Drug Antibodies to LY2944876, Percentage of participants developing anti-drug antibodies to LY2944876., Week 12 and Week 24|Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2944876, Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state., Baseline, Week 8, Week 12, Week 16, Week 20, Week 24|Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2944876, Evaluable pharmacokinetic concentrations from the specified timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state., Baseline, Week 8, Week 12, Week 16, Week 20, Week 24|Change From Baseline in Adiponectin Levels, LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect., Baseline, Week 12; Baseline, Week 24|Change From Baseline in Beta-Hydroxy Butyrate Levels, LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect., Baseline, Week 12; Baseline, Week 24|Change From Baseline in Glucagon Levels, LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect., Baseline, Week 12; Baseline, Week 24|Change From Baseline in Insulin Levels, LSM are calculated from MMRM analysis using REML with metformin use, baseline BMI category, baseline HbA1c category, country, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline parameter result as a covariate, and participant as a random effect., Baseline, Week 12; Baseline, Week 24
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| Locations: |
John Muir Physician Network Clinical Research Center, Concord, California, 94520, United States|Valley Endocrine, Fresno, Fresno, California, 93720, United States|National Research Institute, Los Angeles, California, 90057, United States|Desert Medical Group Inc, Palm Springs, California, 92262, United States|Artemis Institute for Clinical Research, San Diego, California, 92103, United States|Encompass Clinical Research, Spring Valley, California, 91978, United States|Meridien Research, Bradenton, Florida, 34208, United States|M & O Clinical Research, LLC, Fort Lauderdale, Florida, 33316, United States|Suncoast Research Group, LLC, Miami, Florida, 33135, United States|Suncoast Clinical Research, New Port Richey, Florida, 34652, United States|Compass Research, Oviedo, Florida, 32765, United States|Clinical Research of Central Florida, Winter Haven, Florida, 33880, 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|Iderc, P.L.C., Des Moines, Iowa, 50314, United States|Cotton O'Neil Diabetes and Endocrinology Center, Topeka, Kansas, 66606, United States|St John's Mercy Medical Center, Saint Louis, Missouri, 63141, United States|Mercy Medical Research Institute, Springfield, Missouri, 65807, United States|Mercy Health Research, Washington, Missouri, 63090, United States|Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, 03063, United States|High Point Clinical Trials Center, High Point, North Carolina, 27265, United States|Lillestol Research LLC, Fargo, North Dakota, 58103, United States|The Corvallis Clinic P.C., Corvallis, Oregon, 97330, United States|Blair Medical Associates, Inc., Altoona, Pennsylvania, 16602, United States|Texas Diabetes and Endocrinology, Austin, Texas, 78731, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States|San Gabriel Clinical Research, Georgetown, Texas, 78626, United States|Oakwell Clinical Research, San Antonio, Texas, 78218, United States|Southwest Health Associates, P.A., Sugar Land, Texas, 77478, United States|Wade Family Medicine, Bountiful, Utah, 84010, 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., Ampelokipoi, 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., 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, 57010, 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., Chihuahua, 31238, Mexico|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., Guadalajara, 44690, Mexico|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., Tampico, 89000, Mexico|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., Bialystok, 15-351, Poland|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., Gdansk, 80-546, Poland|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., Gdynia, 81-553, Poland|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., Lodz, 90-242, Poland|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., Poznan, 61-853, Poland|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., Szczecin, 70-506, Poland|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., Warsaw, 01-518, Poland|Manati Medical Center, Manati, 00674, Puerto Rico|American Telemedicine Center, San Juan, 00917-3104, 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., Cluj-Napoca, 400349, Romania|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., Iaşi, 700547, Romania|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., Ploiesti, 100342, Romania|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., Targu Mures, 540098, Romania|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., Timisoara, 300456, Romania
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