| Outcome Measures: |
Primary: Percentage of Participants With Any Adverse Experience, An adverse event (AE) is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the product., Up to 26 weeks|Change From Baseline to Treatment in Hemoglobin HbA1c (A1C) at Week 12, HbA1C is found when high blood levels of glucose combines with hemoglobin to form glycated hemoglobin. The average amount of glucose in blood over a prolonged periods of time can be determined by measuring a hemoglobin A1c level which is reported as a percentage (%). The change from baseline reflects the Week 12 A1C minus Week 0 A1C., Baseline and Week 12|Change From Baseline to Treatment in Fasting Plasma Glucose (FPG) at Week 12, Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 FPG minus Week 0 FPG., Baseline and Week 12|Change From Baseline in 2-hour Post Prandial Glucose (2hr-PPG) at Week 12, Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 12 2hr-PPG minus Week 0 2hr-PPG., Baseline and Week 12|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 12, Overall efficacy analysis was conducted on participants who have used study drug for more than 12 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form., At Week 12|Change From Baseline to Treatment in HbA1c at Week 24, HbA1C is blood marker used to report average blood glucose levels over a prolonged periods of time and is reported as a percentage (%). Therefore, this change from baseline reflects the Week 24 A1C minus Week 0 A1C., Baseline and Week 24|Change From Baseline to Treatment in FPG at Week 24, Blood glucose was measured on a fasting basis (collected after an 8- to 10-hour fast). FPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 FPG minus Week 0 FPG., Baseline and Week 24|Change From Baseline in 2hr-PPG at Week 24, Blood glucose was measured 2 hours after a meal (2hr-PPG). 2hr-PPG is expressed as mg/dL. Therefore, this change from baseline reflects the Week 24 2hr-PPG minus Week 0 2hr-PPG., Baseline and Week 24|Percentage of Participants With an Overall Efficacy Evaluation by the Investigator of Improved, Stable, or Worse at Week 24, Overall efficacy analysis was conducted on participants who have used study drug for more than 24 weeks and whose improvement of the disease has been assessed by Principal investigator. The investigator's global assessment of disease improvement was classified as either: "Improved", "Stable" and "Worse" in a Medical History/Physical Examination form., At Week 24 |
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