| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c) (LY2963016 Noninferior to Lantus®), HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean was calculated using mixed-effects model for repeated measures (MMRM) with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares)., Baseline, Week 24 | Secondary: Change From Baseline in HbA1c (Lantus® Noninferior 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 using MMRM with variables baseline HbA1c + Treatment + Pre-study treatment + Pre-study metformin or acarbose usage + Time + Time\*Treatment (Type III sum of squares)., Baseline, Week 24|Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values, The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Before Morning Meal Glucose, 2 Hours After Morning Meal Glucose, Before Mid-Day Meal Glucose, 2 Hours After Mid-Day Meal Glucose, Before Evening Meal Glucose, Bedtime Glucose and 0300 Am Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 24|Percentage of Participants With HbA1c <7%, HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time., Week 24|Percentage of Participants With HbA1c ≤6.5%, HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time., Week 24|Change From Baseline in Intrapatient Blood Glucose (BG) Variability, Measured by the Standard Deviation of 7-point SMBG, Change From Baseline in Intrapatient blood glucose (BG). LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 24|Change From Baseline in Glycemic Variability of Fasting Blood Glucose, Change From Baseline in Glycemic Variability of Fasting Blood Glucose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 24|Change From Baseline in Basal Insulin Dose, Change from baseline in basal insulin dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured., Baseline, Week 24|Change From Baseline in Prandial Insulin Dose, Prandial Insulin Dose. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured., Baseline, Week 24|Change From Baseline in Body Weight, Change from baseline in body weight. LS mean was calculated using MMRM with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment + Time + Treatment\*Time (Type III sum of squares). Variance-Covariance structure (Actual Measurement) = Unstructured. Variance-Covariance structure (Change from Baseline) = Unstructured., Baseline, Week 24|Change From Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ), The ITSQ is a validated 22-item questionnaire that was used to assess treatment satisfaction. Items were measured on a 7-point scale, with lower scores reflecting better outcomes. In addition to an overall score, scores were also obtained for 5 domains, including inconvenience of regimen, lifestyle flexibility, glycemic control, hypoglycemic control, and insulin delivery device. Raw domain and overall scores were transformed on a scale from 0 to 100, where a higher score indicated better treatment satisfaction. LS mean was calculated using ANCOVA with variables Baseline + Pre-study Treatment + Pre-study Metformin or Acarbose Usage + HbA1c at Baseline + Treatment (Type III sum of squares)., Baseline, Week 24|Number of Participants With Detectable Anti-Glargine Antibodies, Number of participants with detectable anti-glargine antibodies, Baseline through Week 24|Rate of Documented Symptomatic Hypoglycemia, 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 (patient's treatment duration/365.25) as an offset variable., Baseline through Week 24
|
| Locations: |
Peking University Peoples Hospital, Beijing, Beijing, 100044, 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|Wu Han Tongji Hospital, Wu Han, Hu Bei, 430030, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China|Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213003, China|The Second Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210011, China|Nanjing First Hospital, Nanjing, Jiangsu, 210012, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212001, China|No.2 Hospital Affiliated to Jilin University, Changchun City, Jilin, 130041, China|Dalian Med. Univ. No 2 Affiliate Hospital, Dalian, Liao Ning, 116023, China|The First Affiliated Hospital with Nanjing Medical Universit, Nanjing, Nanjing, 210029, China|Shanghai Tenth People's Hospital, Shanghai, Shanghai, 200072, China|West China Hospital of Sichuan University, Chengdu, Sichuan, 610041, China|First People's Hospital of Yunnan Province, Kunming, Yunnan, 650034, China|Peking Union Medical College Hospital, Beijing, 88798, China|Shanghai Putuo District Center Hospital, Shanghai, 200062, China
|
