| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c), HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 26 | Secondary: 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT), A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares)., Week 26|2-hour PPG Excursion During MMTT, A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares)., Week 26|Rate of Severe Hypoglycemia, Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group \*36525., Baseline through Week 26|Rate of Documented Symptomatic Postmeal Hypoglycemia, Documented symptomatic postmeal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL \[3.9 millimole per liter (mmol/L)\]. The rate of documented symptomatic postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable, Baseline through Week 26|Change From Baseline in 1,5-Anhydroglucitol (1,5-AG), 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares), Baseline, Week 26|Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values, SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares)., Baseline, Week 26|Change From Baseline in Insulin Dose, LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares), Baseline, Week 26|Percentage of Participants With HbA1c <7% and ≤6.5%, Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis., Week 26
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| Locations: |
Centro Médico Viamonte, Buenos Aires, Ar-c, C1120AAC, Argentina|Centro de Investigaciones Metabólicas (CINME), Caba, Buenos Aires, C1056ABJ, Argentina|Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC, Cordoba, X5008HHW, Argentina|Beijing Pinggu District Hospital, Beijing, Cn-11, 101200, China|Tianjin Medical University General Hospital, Tianjin, Cn-12, 300052, China|Cangzhou People's Hospital, Cangzhou, Cn-13, 061000, China|The First Hospital of Qinhuangdao, Qinhuangdao Shi, Cn-13, 066000, China|Inner Mongolia People's Hospital, Hohhot, Cn-15, 010017, China|Dalian Municipal Central Hospital Affiliated of Dalian Medical University, Dalian, Cn-21, 116033, China|Shengjing Hospital of China Medical University, Shenyang, Cn-21, 110004, China|Shanghai Putuo District Center Hospital, Shanghai, Cn-31, 200062, China|Shanghai 6th people's hospital, Shanghai, Cn-31, China|The Affiliated Jiangyin Hospital of Southeast University Medical College, Jiangyin, Cn-32, 214400, China|Zhongda Hospital Southeast University, Nanjing, Cn-32, 210009, China|Nanjing Medical University - Nanjing Jiangning Hospital, Nanjing, Cn-32, 211100, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Cn-32, 212000, China|The Third Hospital of Nanchang, Nanchang, Cn-36, 330009, China|The Central Hospital of Wuhan, Wuhan, Cn-42, China|The First People's Hospital of Yueyang, Yueyang, Cn-43, 414000, China|Chongqing General Hospital, Chongqing, Cn-50, 400014, China|Fujian Medical University Union Hospital, Fuzhou, Fujian, 350001, China|Xingtai People's Hospital, Xingtai, Hebei, 054031, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The First Hospital of Qiqihar, Qiqihar, Heilongjiang, 161006, China|The First Affiliated Hospital of Henan University of Science &Technology, Luoyang, Henan, 471003, China|Wuhan Pu'ai Hospital, Wuhan, Hubei, 430000, China|Yichang Central People's Hospital, Yichang, Hubei, 443003, China|Chenzhou NO.1 People's Hospital, Chenzhou, Hunan, 424300, China|Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213003, China|The First Hospital of Nanjing, Nanjing, Jiangsu, 210012, China|China-Japan Union Hospital, CJUH., Changchun, Jilin, 130033, China|Siping Central People's Hospital, Siping, Jilin, 136000, China|Qinghai University Affiliated Hospital, Xining, Qinghai, 810001, China|Jinan Central Hospital, Jinan, Shandong, 250013, China|The First Affiliated Hospital of Xi'an Medical University, XI 'an, Shanxi, China|Beijing Peking Union Medical College Hospital, Beijing, 100730, China|Pingxiang People's Hospital, Pingxiang, 337000, China|Unidad de patologia Clinica, Guadalajara, Jalisco, 44650, Mexico|Centro de Inv. Medica de Occidente, SC, Zapopan, Jalisco, 45116, Mexico|Unidad Médica para la Salud Integral, San Nicolás de los Garza, Mx-nle, 66465, Mexico|Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, N.l., 64460, Mexico
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