| Primary | Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1 | Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure. | Intent-to-treat (ITT) analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (greater than [>] 70% of tracings available). | Posted | | Mean | Standard Deviation | Percentage of CV | | Baseline up to End of Treatment Period 1 (Days 22 to 27) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| | | Title | Measurements |
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| - OG000-0.69± 5.17
- OG0010.24± 10.23
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| Primary | Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2 | Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure. | ITT analysis set included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful (>70% of tracings available). | Posted | | Mean | Standard Deviation | Percentage of CV | | Baseline up to End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | |
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| Secondary | Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile | Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure. | Per-protocol (PP) analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | |
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| Secondary | Change From Baseline in Mean 24-hour Glucose Profile | Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose Levels | Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| Secondary | Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels | 2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| Secondary | Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL | Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all intent-to-treat participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | |
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| Secondary | Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL | Percent change from baseline in time during 24 hours within the glucose levels >140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | |
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| Secondary | Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL | Percent change from baseline in time during 24 hours within the glucose levels >180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | |
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| Secondary | Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL | Percent change from baseline in time during 24 hours within the glucose levels < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Percent Change | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | |
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| Secondary | Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL | Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Minutes | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| Secondary | Change From Baseline in Time Spent With Glucose Level > 140 mg/dL | Time spent with the glucose level > 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Minutes | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| Secondary | Change From Baseline in Time Spent With Glucose Level > 180 mg/dL | Time spent with the glucose level > 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Minutes | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| Secondary | Change From Baseline in Time Spent With Glucose Level < 70 mg/dL | Time spent with the glucose level < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Minutes | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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| Secondary | Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL | The percentage of 2 consecutive glucose readings with < 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure. | PP analysis set included all ITT participants without a major protocol violation, where ITT population included all participants who received at least one dose of medication and in whom CGM recordings at baseline and after each active treatment were successful. | Posted | | Mean | Standard Deviation | Percentage of readings | | Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71) | | | | ID | Title | Description |
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| OG000 | Treatment Sequence AB | Participants received metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from Days 28 to 43) along with ongoing metformin monotherapy. | | OG001 | Treatment Sequence BA | Participants received metformin monotherapy at stable doses >=1500 mg/day with sitagliptin 100 mg tablet orally once daily (Treatment B) from Day 0 to 27 (treatment Period 1), followed by metformin >= 1500 mg/day orally once daily with canagliflozin 300 mg tablet orally once daily (Treatment A) from Day 44 to 71 (treatment period 2), under fasted condition with a washout period of 16 days (from days 28 to 43) along with ongoing metformin monotherapy. |
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