| Outcome Measures: |
Primary: Change From Baseline to 26 Weeks in Hemoglobin A1c (HbA1c), Glycosylated hemoglobin A1 (HbA1c) is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated by mixed model repeated measures (MMRM) using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects., Baseline, 26 Weeks | Secondary: 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events, Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Group mean rates of total and nocturnal hypoglycemia (per 30 days) are presented and were calculated from negative binomial regression models with treatment, baseline sulfonylurea/meglitinide use, baseline event rate of the corresponding hypoglycemia as covariates, log (exposure/30 days) as the offset in the model. Group Mean is estimated by taking the inverse link function on individual participant covariates first and then averages over all participants., Baseline through 26 Weeks|Percentage of Participants With HbA1c ≤6.5% and <7.0%, Percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100., 26 Weeks|Fasting Serum Glucose (FSG) (by Laboratory), LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), baseline HbA1c strata \[≤8.5% or \>8.5%\]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects., 26 Weeks|Fasting Blood Glucose (FBG) (by Self Monitoring), LS means were calculated from MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), baseline HbA1c strata \[≤8.5% or \>8.5%\]), visit, treatment-by-visit interaction, and baseline value of the response variable as the fixed effects., 26 Weeks|6-Point Self-Monitored Blood Glucose (SMBG), 6-point SMBG profiles were obtained on 3 nonconsecutive days in the week prior to Weeks 0, 4, 8, 12, 16, and 26. The SMBG measurements were performed while fasting (prior to the morning meal \[breakfast\]), prior to the midday meal (lunch), prior to the evening meal (dinner), at bedtime, at approximately 0300 hours, and the next day fasting (prior to the morning meal). LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), \], baseline HbA1c strata \[≤8.5% or \>8.5%\]), visit, treatment-by-visit interaction, and baseline SMBG at the same time point of the response variable as the fixed effects., 26 Weeks|Change From Baseline to 26 Weeks in Body Weight, LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), baseline HbA1c strata \[≤8.5% or \>8.5%\]), visit, treatment-by-visit interaction, and baseline weight as the fixed effects., Baseline, 26 Weeks|HbA1c, HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), visit, treatment-by-visit interaction, and baseline HbA1c as the fixed effects., 26 Weeks|Insulin Dose Per Kilogram (kg) of Body Weight, LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\]), baseline HbA1c strata \[≤8.5% or \>8.5%\]), visit, and treatment-by-visit interaction as the fixed effects., 26 Weeks|Time to Steady-State (Stable Maximum Dose), Steady-state was defined as the first local maximum dose (peak dose value) of LY2605541 or human insulin NPH within the window of -2 to +2 weeks. The median time to steady-state of basal insulin dose estimated from Kaplan-Meier analysis was summarized by treatment., Baseline through 26 Weeks|Change From Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EQ-5D-3L) Index, The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a three level scale 1-3 (no problem, some problems, and extreme problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United States (US) population-based algorithm. The EQ-5D-3L US based index scores ranged from -0.11 to 1.0 where a score of 1.0 indicates perfect health. LS means were calculated from ANCOVA using treatment, stratification factor (country, baseline sulfonylurea sulfonylureas/meglitinide use \[Yes/No\], baseline HbA1c strata \[≤8.5% or \>8.5%\]) and baseline value of EQ-5D-3Las covariates., Baseline, 26 Weeks|Insulin Treatment Satisfaction Questionnaire (ITSQ) Score, ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. The questionnaire measures satisfaction from the following 5 domains: Inconvenience of Regimen, Lifestyle Flexibility, Glycemic Control, Hypoglycemic Control, Insulin Delivery Device. Data presented are the transformed score on a scale of 0-100, higher scores indicate better treatment satisfaction. LS means were calculated using analysis of variance (ANOVA) adjusting for treatment and stratification factors (country, baseline sulfonylureas/meglitinide use \[Yes/No\], baseline HbA1c \[≤8.5% or \>8.5%\])., 26 Weeks|Change From Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores, Adult LBSS (also referenced as Hypoglycemia Fear Survey - II \[HFS-II\]) contains 33 items, with each item scored on a 5-point response scale: 0 (never) to 4 (always). Items are categorized in 2 domains: Behavior (or avoidance) with 15 items and Worry (or affect) with 18 items. Sum all the items to obtain a total score (range 0-132). Higher total scores reflect greater fear of hypoglycemia. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, stratification factor (country, baseline sulfonylureas/meglitinide use \[Yes/No\]), baseline HbA1c (≤8.5% or \>8.5%), and baseline value of LBSS., Baseline, 26 Weeks|Change From Baseline to 26 Weeks in Lipid Profile, Lipid profile includes total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglycerides. LS means for post-baseline measures were calculated using MMRM with the fixed effects of stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, sulfonylureas/meglitinide use, and LDL-C \[\<100 mg/dL and ≥100 mg/dL\], except for the LDL-C outcome variable), visit, treatment, visit-by-treatment interaction, and baseline value of corresponding lipid outcome variable. LS means for End Of Study measures were calculated using ANCOVA adjusting for stratification factors (baseline HbA1c \[≤8.5% and \>8.5%\], country, sulfonylureas/meglitinide use, and LDL-C \[\<100 mg/dL and ≥100 mg/dL\]except for the LDL-C outcome variable), treatment, and baseline value of corresponding lipid outcome variable., Baseline, 26 Weeks; Baseline, End Of Study (EOS) (Up to 30 Weeks)|Percentage of Participants With Insulin Antibodies, The percentage of participants with a positive treatment-emergent anti-LY2605541 antibody response (TEAR) is summarized. TEAR was defined as change from baseline to postbaseline in the anti-LY2605541 antibody level either (1) from undetectable to detectable or (2) from detectable to the value with at least 130% relative increase from baseline. Percentage of participants was calculated by dividing the number of participants with TEAR anytime during the treatment period by the total number of participants analyzed, multiplied by 100., Baseline to 26 Weeks|Intra-Participant Variability in FBG by Standard Deviation, Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG. LS means were calculated by MMRM using treatment, stratification factors (country, sulfonylureas/meglitinide use \[Yes/No\], baseline HbA1c strata \[≤8.5% or \>8.5%\]), visit, treatment-by-visit interaction, and baseline FBG variability as the fixed effects., 26 Weeks|Intra-Participant Variability in FBG by the Coefficient of Variation, Glucose variability was assessed by between-day variability as measured by the standard deviation or the coefficient of variation of the FBG of the last 7 days prior to the visit using SMBG., 26 Weeks|Percentage of Participants With Total and Nocturnal Hypoglycemic Events, Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants with at least one hypoglycemia divided by the total number of participants analyzed, multiplied by 100., Baseline through 26 Weeks|Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia, Hypoglycemic episodes are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]). A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking. Percentage of participants was calculated by the number of participants reaching target HbA1c without nocturnal hypoglycemia divided by the total number of participants analyzed, multiplied by 100., 26 Weeks|Percentage of Participants With Injection Site Reactions, The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module., Baseline through 26 Weeks|Rate of Severe Hypoglycemic Events, Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The hypoglycemia rate per 100 years during a defined period was calculated by the number of hypoglycemia events within the period divided by the number of days participant at risk within the period\*36525 days., Baseline through 26 Weeks|Percentage of Participants With Severe Hypoglycemic Events, Hypoglycemic event are defined as an event which is associated with reported signs and symptoms of hypoglycemia, and/or a documented blood glucose (BG) concentration of \<=70 milligram per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]). A severe hypoglycemic event was defined as a hypoglycemic episode requiring assistance of another person to actively administer carbohydrates, glucagon, or other resuscitative actions. The percentage of participants with at least one severe hypoglycemia is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module., Baseline through 26 Weeks|Change From Baseline to 26 Weeks in European Quality of Life (EQ-5D-3L) - Visual Analog Scales (VAS) Scores, The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument. Overall health state score was self-reported using a visual analogue scale (VAS) marked on a scale of 0 to 100 with 0 representing worst imaginable health state and 100 representing best imaginable health state., Baseline, 26 Weeks
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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., Tempe, Arizona, 85283, 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., Concord, California, 94520, 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., Fresno, California, 93720, 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., Lancaster, California, 93534, 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., Los Angeles, California, 90057, 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., Spring Valley, California, 91978, 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., Tustin, California, 92780, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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