| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint, 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) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect., Baseline, Week 12 | Secondary: Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint, HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time., Week 12|Percentage of Participants That Require Rescue Therapy, Percentage of participants that required \>=1 rescue (blood glucose lowering) medications., Baseline through Week 12|Change From Baseline in Body Weight at 12-Week Endpoint, LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy)., Baseline, Week 12|Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint, 7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy)., Baseline, Week 12|Change From Baseline in Lipids at 12-Week Endpoint, Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy)., Baseline, Week 12|Percentage of Participants With Anti-Drug Antibodies to LY3053102, Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value., Baseline through Study Completion (Up to 6 Months)|Percentage of Participants With Hypoglycemia, Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia., Baseline through Week 12|Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]), LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy)., Baseline, Week 12|Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]), LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy)., Baseline, Week 12|Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint, LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy)., Baseline, Week 12|Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102, AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours., Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose
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| Locations: |
Orange County Research Center, Orange, California, 92868, United States|Miami Research Associates, Miami, Florida, 33143, United States|Compass Research, Orlando, Florida, 32806, United States|Clinilabs, Inc (New York), New York, New York, 10019, United States|Dallas Diabetes Endocrine Center, Dallas, Texas, 75230, United States
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