| Outcome Measures: |
Primary: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population, HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive., Baseline and every study visit up to 24 weeks|Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population, HbA1c analysis will be performed on a blood sample obtained by study personnel at every visit and measured by ion exchange HPLC. Study endpoint is defined as final available post- randomization assessment obtained at any visit prior to or at the start of major change in insulin use, up to final scheduled study visit (week 24 visit) inclusive., Baseline and every study visit up to 24 weeks | Secondary: Number of patients with adverse events, serious adverse events and death on over all population, Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards., 24 weeks|Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG)on overall population, FPG will be performed on the blood samples collected at all every study visits from baseline to week 24., Baseline, week 24|Percentage of patients meeting responder criteria after 24 weeks treatment on overall population, Responder rate will be analyzed in the following categories: * Endpoint HbA1c ≤ 6.5% * Endpoint HbA1c \< 7% * Endpoint HbA1c \<7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed, After 24 weeks|Number of patients with adverse events, serious adverse events and death on Chinese population, Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards., 24 weeks|Change from baseline after 24 weeks of treatment in fasting plasma glucose (FPG) on Chinese population, FPG will be performed on the blood samples collected at all every study visits from baseline to week 24., Baseline, week 24|Percentage of patients meeting responder criteria after 24 weeks treatment on Chinese population, Responder rate will be analyzed in the following categories: • Endpoint HbA1c ≤ 6.5% • Endpoint HbA1c \< 7% • Endpoint HbA1c \<7% in patients with baseline HbA1c ≤ 8% The percentage of patients meeting each of the responder criteria as described, as well as the percentage of patients meeting any of these criteria in each treatment group will be computed, After 24 weeks
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| Locations: |
Novartis Investigative Site, Beijing, Beijing, 100730, China|Novartis Investigative Site, Changsha City, Hunan, 410011, China|Novartis Investigative Site, Changsha, Hunan, 410003, China|Novartis Investigative Site, Nanjing, Jiangsu, 210006, China|Novartis Investigative Site, Wu Xi, Jiangsu, 214023, China|Novartis Investigative Site, Nanchang, Jiangxi, 330006, China|Novartis Investigative Site, Shenyang, Liaoning, 110003, China|Novartis Investigative Site, Jinan, Shandong, 250031, China|Novartis Investigative Site, Xi'an, Shanxi, 710032, China|Novartis Investigative Site, Chengdu, Sichuan, 610072, China|Novartis Investigative Site, Beijing, China|Novartis Investigative Site, Shanghai, 200025, China|Novartis Investigative Site, Tianjin, 300052, China|Novartis Investigative Site, Metro Manila, 1500, Philippines|Novartis Investigative Site, Pasay City, 1300, Philippines|Novartis Investigative Site, Quezon City, 1102, Philippines|Novartis Investigative Site, Singapore, 169608, Singapore|Novartis Investigative Site, Singapore, 768825, Singapore|Novartis Investigative Site, Bangkok, 10330, Thailand|Novartis Investigative Site, Bangkok, 10400, Thailand|Novartis Investigative Site, Khon Kaen, 40002, Thailand
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