Outcome Measures: |
Primary: Change in HbA1c from baseline, To demonstrate non-inferiority of Dapa/Met FDC regimen when compared with Dapa + Met co-administered with respect to the primary efficacy endpoint., 24 weeks | Secondary: Proportion of patients achieved HbA1c less than 7.0% from baseline to week 24., To describe the changes from baseline at Week 24 in proportion of patients with HbA1c \< 7%., 24 weeks|Absolute change in FPG from baseline to week 24., To describe the changes from baseline at Week 24 in fasting plasma glucose (FPG)., 24 weeks|Absolute change in PPG from baseline to week 24., To describe the changes from baseline at Week 24 in postprandial glucose (PPG)., 24 weeks|The difference in satisfaction scores between 2 groups measured with the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at week 24., To evaluate the difference in satisfaction of FDC versus co-administered dual therapy in Chinese patients with T2DM. The minimum value is 0, the maximum value is 36, higher scores mean a better outcome., Week 24|The difference in quality of life between 2 groups measured with Diabetes Quality of Life (DQOL) questionnaire at week 12 and week 24., To evaluate the difference in quality of life of FDC versus co-administered dual therapy in Chinese patients with T2DM. DQOL-Satisfaction: the minimum value is 15, the maximum value is 75, higher scores mean a worse outcome. DQOL-Impact: the minimum value is 20, the maximum value is 100, higher scores mean a worse outcome. DQOL-Worry: the minimum value is 11, the maximum value is 55, higher scores mean a worse outcome., Week 12 and Week 24|To evaluate the difference in adherence of FDC versus co-administered dual therapy by Morisky Medication Adherence Scale-8 (MMAS-8) questionnaire in Chinese patients with T2DM., To evaluate the difference in adherence of FDC versus co-administered dual therapy in Chinese patients with T2DM. The minimum value is 0, the maximum value is 8, higher scores mean a better outcome., Week 24 | Other: AEs, An AE can therefore be any unfavourable and unintended sign (eg, an abnormal laboratory finding), symptom (for example nausea, chest pain), or disease temporally associated with the use of a medicinal product, whether it's considered related to the medicinal product., 24 weeks|SAE, An SAE is an AE occurring during any study phase (i.e., run-in, treatment, washout, follow up), that fulfils one or more of the following criteria: Results in death. Is immediately life-threatening. Requires in-patient hospitalization or prolongation of existing hospitalization. Results in persistent or significant disability or incapacity. Is a congenital anomaly or birth defect. Is an important medical event that may jeopardize the participant or may require medical treatment to prevent one of the outcomes listed above., 24 weeks|ADRs, An Adverse Drug Reaction (ADR) is an Adverse Event suspected to be causally related to the medicinal product., 24 weeks|Temperature, Armpit Temperature., 24 weeks|Systolic and diastolic BP, Blood pressure should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position(mmHg)., 24 weeks|Pulse rate, Pulse rate should be measured with a completely automated device in triplicate with at least 1-minute intervals between measurements after being comfortably at rest in a seated position(times/min), 24 weeks|Respiratory rate, Respiratory rate per minute(times/min), 24 weeks|Weight, Weight in kilograms, 24 weeks|Height, Height in meters, 24 weeks|BMI, BMI in kg/m\^2, 24 weeks|Number of participants with abnormal ECG readings, The normality/abnormality of ECG tracings, as determined by the Investigator., 24 weeks|Proportion of TITR (Time in Tight Target Range), The percentage of readings and time that a person spends with their blood glucose levels in a Tight target range (3.9-7.8mmol/L)., Week 12|TIR (Time In Range), The percentage of readings and time that a person spends with their blood glucose levels in a target range (3.9-10mmol/L)., Week 12|TBR (Time Below Range), The percentage of readings and time that a person spends with their blood glucose levels below target range., Week 12|TAR (Time Above Range), The percentage of readings and time that a person spends with their blood glucose levels above target range., Week 12|MAGE (Mean Amplitude of Glycemic Excursion), The mean of blood glucose values exceeding one SD from the 24-hour mean blood glucose and is used as an index of glycemic variability., Week 12|SDBG (Standard Deviation of Blood Glucose), SDBG (Standard Deviation of Blood Glucose), reflects the amount of variation or dispersion of a series of glucose values., Week 12
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Locations: |
Research Site, Beijing, 100020, China|Research Site, Beijing, 100050, China|Research Site, Beijing, 100076, China|Research Site, Beijing, 102218, China|Research Site, Changsha, 410005, China|Research Site, Chengdu, 610072, China|Research Site, Chongqing, 402260, China|Research Site, Chuxiong, 675000, China|Research Site, Dalian, 116001, China|Research Site, Dingzhou, 562100, China|Research Site, Fuyang, 236400, China|Research Site, Guangzhou, 510180, China|Research Site, Guangzhou, 510515, China|Research Site, Guiyang, 550044, China|Research Site, Hefei, 230012, China|Research Site, Jiangyin, 214400, China|Research Site, Jiyuan, 459003, China|Research Site, Kunming, 650032, China|Research Site, Nanchang, 330006, China|Research Site, Nanning, China|Research Site, Nantong, 226001, China|Research Site, Panjin, 124000, China|Research Site, Qingdao, 266200, China|Research Site, Quanzhou, 362000, China|Research Site, Rui'an, 325200, China|Research Site, Shenzhen, 518101, China|Research Site, Suzhou, 215500, China|Research Site, Taiyuan, 030001, China|Research Site, Tianjin, 300134, China|Research Site, Wei Fang, 261035, China|Research Site, Wenzhou, 325000, China|Research Site, Wuhan, 430010, China|Research Site, Yibin, 610500, China|Research Site, Zhengzhou, 450052, China|Research Site, Zhuji, 311899, China
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