| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 to Lantus®), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated by mixed-effects model for repeated measures (MMRM) with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model., Baseline, Week 24 | Secondary: Change From Baseline in HbA1c (Lantus® to LY2963016), HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, treatment, visit and treatment\*visit in the model., Baseline, Week 24|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values, Seven-point SMBG are completed at the following timepoints: Before Morning Meal, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and Bed Time. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model., Baseline, Week 24|Percentage of Participants With HbA1c <7% at Week 24, The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100., Week 24|Percentage of Participants With HbA1c ≤6.5% at Week 24, The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100., Week 24|Change From Baseline in Glycemic Variability of Fasting Blood Glucose, Glycemic variability is measured by the intra-participant standard deviation (SD) value of fasting blood glucose as measured by the actual morning and daily pre-meal blood glucose value from the 7-point self-monitoring blood glucose \[SMBG\] profiles. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model., Baseline, Week 24|Basal Insulin Dose Units Per Day, Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model., At Week 24|Change From Baseline in Basal Insulin Dose Units Per Day, Units of basal insulin dose taken per day (U/day). LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model., Baseline, Week 24|Change From Baseline in Body Weight, Change from baseline in body weight was evaluated. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model., Baseline, Week 24|Insulin Treatment Satisfaction Questionnaire (ITSQ), ITSQ is a validated instrument containing 22 items that assess treatment satisfaction for participants with diabetes and on insulin. Items divided into 5 domains of satisfaction: Inconvenience of Regimen \[(IR) 5 items: domain scores range (DSR) 5-35\], Lifestyle Flexibility \[(LF) 3 items: DSR 3-21\], Glycemic Control \[(GC) 3 items: DSR 3-21\], Hypoglycemic Control \[(HC) 5 items: DSR 5-35\], Insulin Delivery Device \[(IDD) 6 items: DSR 6-42\]. All items measured on a 7-point scale: 1 (no bother at all) to 7 (a tremendous bother), with lower scores reflecting better outcomes. ITSQ Total Overall Raw Scores range from 22-154. Both raw domain and overall scores are transformed on a scale of 0-100, where transformed score=100\*\[(7-mean raw score)/6\]. Higher scores indicate better treatment satisfaction. LS mean was calculated by MMRM with baseline, insulin secretagogues at study entry, baseline HbA1c, treatment, time and treatment\*time in the model., At Week 24|Number of Participants With Detectable Anti-Glargine Antibodies, Number of participants with detectable anti-glargine antibodies were reported., Baseline through 24 weeks|Rate of Total Symptomatic and Nocturnal Hypoglycemia Events (Adjusted by 1 Year), Hypoglycemic episodes are defined as events that are associated with reported signs and symptoms of hypoglycemia and/or documented blood glucose (BG) concentrations of ≤70 mg/dL (3.9 mmol/L). The overall yearly rates (events/participant/year) of those hypoglycemic events, calculated as, for each participant, the number of episodes times 365.25 and then divided by the participants treatment duration, will be summarized, and analyzed by a negative-binomial regression model with treatment as fixed effects and log of (participant's treatment duration/365.25) as an offset variable. A nocturnal hypoglycemic event is defined as any total hypoglycemia event that occurred between bedtime and waking., Baseline through 24 weeks
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| Locations: |
Anhui Provincial Hospital, Hefei, Anhui, 230001, China|The First Affiliated Hospital of Lanzhou University, Lanzhou, Gansu, 730000, China|Shantou University Medical College No.2 Affiliated Hospital, Shantou, Guang Dong Province, 515041, China|Guangdong Province People's Hospital, Guangzhou, Guangdong, 510080, China|The First Affiliated Hospital, Sun-Yat Sen University, Guangzhou, Guangdong, 510080, China|Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, 510120, China|The 1st Affiliated Hospital of Henan Science and technology, Luoyang, Henan, 471003, China|Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech, Wu Han, Hubei, 430030, China|Wuhan Central Hospital, Wuhan, Hubei, 430014, China|The First People Hospital of Yueyang, Yueyang, Hunan, 414000, China|Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213003, China|The Affliated Jiangyin Hospital of Southeast University Medical College, Jiangyin, Jiangsu, 214400, China|Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med, Nanjing, Jiangsu, 210008, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Nanjing First Hospital, Nanjing, Jiangsu, 210012, China|Nanjing Jiangning Hospital, Nanjing, Jiangsu, 211199, China|Wuxi People's Hospital, Wuxi, Jiangsu, 214023, China|Xuzhou central Hospital, Xuzhou, Jiangsu, 221009, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212001, China|No.2 Hospital Affiliated to Jilin University, Changchun City, Jilin, 130041, China|Siping central people's hospital, Siping, Jilin, 136000, China|Dalian Med. Univ. No 2 Affiliate Hospital, Dalian, Liao Ning, 116023, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110022, China|The First Affiliated Hospital with Nanjing Medical Universit, Nanjing, Nanjing, 210029, China|General Hospital of Ningxia Medical University, Yinchuan, Ningxia, 750004, China|1st affiliated Hospital of Shanxi Medical University, Tai Yuan, Shan XI, 030001, China|Jinan Central Hospital, Jinan, Shandong, 250013, China|West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China|Peking Union Medical College Hospital, Beijing, 88798, China|Chongqing General Hospital, Chongqing, 400013, China|Shanghai Putuo District Center Hospital, Shanghai, 200062, China|Tianjin Medical University General Hospital, Tianjin, 300052, China
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