| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (HbA1c), HbA1c is the glycosylated fraction of hemoglobin A. It 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) as variables., 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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables., 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. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables., 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 days., Baseline through Week 26|Rate of Documented Symptomatic Post Meal Hypoglycemia, Documented symptomatic post meal 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 post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group \*365.25., 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. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, Week 26|Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values, SMBG 10-point profiles were measured at morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, Week 26|Change From Baseline in Daily Insulin Dose, LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables., Baseline, Week 26|Percentage of Participants With HbA1c <7% and ≤6.5%, HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time., Week 26
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| Locations: |
Centro de Investigaciones Metabólicas (CINME), Caba, Buenos Aires, C1056ABJ, Argentina|Centro Médico Viamonte, Caba, Buenos Aires, C1120AAC, Argentina|Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC, Cordoba, X5008HHW, Argentina|The Second People's Hospital of Hefei, Hefei, Anhui, 230011, China|Shantou University Medical College No.2 Affiliated Hospital, Shantou, Guang Dong Province, 515041, China|Dongguan people's hospital, Dongguan, Guangdong, 523059, China|Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, 510120, China|Shenzhen Second People's Hospital, Shenzhen, Guangdong, 518039, China|The Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, 150001, China|The First Affiliated Hospital of Henan University of Science &Technology, Luoyang, Henan, 471003, China|The First People's Hospital of Changde City, Changde, Hunan, 415003, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China|Changzhou No.2 People's Hospital, Changzhou, Jiangsu, 213003, China|Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, 210000, China|The First Hospital of Nanjing, Nanjing, Jiangsu, 210006, China|Sir Run Run Hospital of Nanjing Medical University, Nanjing, Jiangsu, 211166, China|The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215004, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212000, China|No.2 Hospital Affiliated to Jilin University, Changchun City, Jilin, 130041, China|The First Hospital of Jilin University, Changchun, Jilin, 130021, China|Shengjing Hospital of China Medical University, Shenyang, Liaoning, 110004, China|Jiangsu Province Hospital, Nanjing, Nanjing, 210029, China|Shanghai Tenth People's Hospital, Shanghai, Shanghai, 200072, China|West China Hospital Sichuan University, Chengdu, Sichuan, 610041, China|Beijing Peking Union Medical College Hospital, Beijing, 100730, China|Shanghai Putuo District Center Hospital, Shanghai, 200062, China|Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, 200092, China|Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente, Guadalajara, Jalisco, 44150, Mexico|Unidad de patologia Clinica, Guadalajara, Jalisco, 44650, Mexico|Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, N.l., 64460, Mexico
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