| Outcome Measures: |
Primary: Mean Change in Glycosylated 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) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction., Baseline, Week 12 | Secondary: Change From Baseline Values for Fasting Blood Glucose (FBG), LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction., Baseline, Week 12|Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT), LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use., Baseline, Week 12|Change From Baseline to Endpoint for Fasting Triglycerides, LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use., Baseline, Week 12|Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R), The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms., Baseline, Week 12|Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021), The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects., Baseline, Week 12|Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles, Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction., Baseline, Week 12|Change From Baseline Values for Fasting Insulin, LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction., Baseline, Week 12|Change From Baseline Values for Fasting Glucagon, LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction., Baseline, Week 12|Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1), LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction., Baseline, Week 12|Change From Baseline for Insulin AUC From OGTT, LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use., Baseline, Week 12|Change From Baseline for C-Peptide AUC From OGTT, LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use., Baseline, Week 12|Change From Baseline to Endpoint for Low Density Lipoprotein (LDL), Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment., Baseline, Week 12|Change From Baseline to Endpoint for High Density Lipoprotein (HDL), Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment., Baseline, Week 12|Change From Baseline to Endpoint for Non-HDL Cholesterol, Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment., Baseline, Week 12|Change From Baseline to Endpoint for Total Cholesterol, Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment., Baseline, Week 12
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| Locations: |
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., Buena Park, California, 90620, 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., Huntington Park, California, 90255, 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., Westlake Village, California, 91361, 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., Fort Lauderdale, Florida, 33306, 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., Jupiter, Florida, 33458, 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., New Port Richey, Florida, 34652, 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., Idaho Falls, Idaho, 83404, 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., Topeka, Kansas, 66606, 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., Madisonville, Kentucky, 42431, 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., Las Vegas, Nevada, 89101, 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., Rapid City, South Dakota, 57702, 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., San Antonio, Texas, 78229, 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., Norfolk, Virginia, 23502, 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., Aschaffenburg, 63739, Germany|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., Mainz, 55116, Germany|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., Munchen, 80336, Germany|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., Saarlouis, 66740, Germany|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., Kaunas, LT-51270, Lithuania|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., Vilnius, LT-08661, Lithuania
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