| Outcome Measures: |
Primary: Change From Baseline in Plasma A1C Levels at Week 12, A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 12 level., Baseline (Week 0) and Week 12|Percentage of Participants Who Experienced at Least One Adverse Event During the Base Period, An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue., Up to 16 weeks (including 28 days following the last dose of study drug)|Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event During the 12-week Base Period, An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue., Up to 12 weeks|Percentage of Participants Who Experienced at Least One Adverse Event During the 66-week Extension Period, An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue., Up to 70 Weeks (Weeks 12 to 78 plus 4-week follow-up period)|Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event During the 66-week Extension Period, An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product, is also an adverse event. Data presented below excludes data after the initiation of glycemic rescue., Up to 66 weeks (Weeks 12 to 78) | Secondary: Change From Baseline in 2 Hour-post-meal Glucose (2h-PMG) Levels at Week 12, Change from baseline was calculated by subtracting the baseline level from the Week 12 level., Baseline (Week 0) and Week 12|Change From Baseline in Fasting Plasma Glucose (FPG) Levels at Week 12, Change from baseline was calculated by subtracting the baseline level from the Week 12 level., Baseline (Week 0) and Week 12|Mean Plasma A1C Level at Baseline of the Extension Period, A1C levels were measured as a percent at baseline (Week 0) for participants who entered the extension period., Baseline (Week 0)|Change From Baseline in Plasma A1C Levels at Week 78, A1C levels were measured as a percent. Change from baseline was calculated by subtracting the baseline level from the Week 78 level., Baseline (Week 0) and Week 78|Mean 2h-PMG Level at Baseline of the Extension Period, Plasma 2h-PMG levels were measured at baseline (Week 0) for participants who entered the extension period., Baseline (Week 0)|Change From Baseline in 2h-PMG at Week 78, Change from baseline was calculated by subtracting the baseline level from the Week 78 level., Baseline (Week 0) and Week 78|Mean FPG Level at Baseline of the Extension Period, Plasma FPG levels were measured at baseline (Week 0) for particiapnts who entered the extension period., Baseline (Week 0)|Change From Baseline in FPG Levels at Week 78, Change from baseline was calculated by subtracting the baseline level from the Week 78 level., Baseline (Week 0) and Week 78
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